FDA Device Registration & Listing · Santo Domingo, DO · Registration 3017636737
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2026-01-22 |
| JYS | Perforator, Ear-Lobe | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-04-28 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-11-24 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FMG | Stopcock, I.V. Set | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | Class 2 | 878.4580 | 2025-11-25 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2025-11-26 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2025-11-25 |
| ETA | Replacement, Ossicular Prosthesis, Total | Ear, Nose, Throat | Class 2 | 874.3495 | 2025-11-25 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2025-11-26 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2025-11-26 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2025-11-25 |
| FMG | Stopcock, I.V. Set | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | Class 2 | 876.5820 | 2025-11-24 |
| KOC | Accessories, Blood Circuit, Hemodialysis | Gastroenterology, Urology | Class 2 | 876.5820 | 2025-11-24 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| JCY | Catheter, Infusion | General, Plastic Surgery | Class 1 | 878.4200 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| LBN | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | Ear, Nose, Throat | Class 2 | 874.3495 | 2025-11-25 |
| LCJ | Tissue Expander And Accessories | Unknown | Class U | N/A | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | Class 2 | 882.1870 | 2025-11-25 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2025-11-25 |
| KGY | Bag, Intestine | General, Plastic Surgery | Class 1 | 878.4100 | 2025-11-25 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2026-01-22 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2025-11-25 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| KYB | Lens, Guide, Intraocular | Ophthalmic | Class 1 | 886.4300 | 2025-11-24 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| ETB | Prosthesis, Partial Ossicular Replacement | Ear, Nose, Throat | Class 2 | 874.3450 | 2025-11-25 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2025-11-25 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-11-24 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | Class 2 | 890.1375 | 2025-11-25 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2019-01-14 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2026-01-22 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FNP | Urinal | General Hospital | Class 1 | 880.6730 | 2025-11-25 |
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | Class 2 | 870.2870 | 2022-01-04 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-04-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| ETA | Replacement, Ossicular Prosthesis, Total | Ear, Nose, Throat | Class 2 | 874.3495 | 2025-11-25 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2025-11-26 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| ETB | Prosthesis, Partial Ossicular Replacement | Ear, Nose, Throat | Class 2 | 874.3450 | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| LFB | Button, Nasal Septal | Unknown | Class U | N/A | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | Class 2 | 870.2870 | 2025-11-25 |
| ETB | Prosthesis, Partial Ossicular Replacement | Ear, Nose, Throat | Class 2 | 874.3450 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FMG | Stopcock, I.V. Set | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-11-24 |
| MFK | Lens, Multifocal Intraocular | Ophthalmic | Class 3 | 886.3600 | 2025-11-21 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2025-11-25 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2025-11-25 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2025-11-25 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2025-11-24 |
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | Class 1 | 874.4780 | 2025-11-25 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-11-25 |
| EXF | Bag, Bile Collecting | Gastroenterology, Urology | Class 2 | 876.5010 | 2026-01-22 |
| GXZ | Electrode, Needle | Neurology | Class 2 | 882.1350 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-25 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2025-11-26 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2025-11-26 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2012-11-16 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-11-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2025-11-25 |
| ETB | Prosthesis, Partial Ossicular Replacement | Ear, Nose, Throat | Class 2 | 874.3450 | 2025-11-25 |
| MIJ | Needle, Tumor Localization | General, Plastic Surgery | Class 1 | 878.4800 | 2015-10-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2025-11-24 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2025-11-25 |
| SCV | Modular Electromechanical Surgical System | General, Plastic Surgery | Class 2 | 878.4964 | 2025-12-10 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2025-11-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| MMZ | Table, Cystometric, Electric | Gastroenterology, Urology | Class 2 | 876.4890 | 2026-03-30 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-11-24 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2026-04-24 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| ETA | Replacement, Ossicular Prosthesis, Total | Ear, Nose, Throat | Class 2 | 874.3495 | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2026-04-24 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-04-24 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4760 | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-11-24 |
| LBM | Porous Polyethylene Ossicular Replacement | Ear, Nose, Throat | Class 2 | 874.3450 | 2025-11-25 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-25 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2025-11-24 |
| MAJ | Catheter, Percutaneous, Intraspinal, Short Term | Anesthesiology | Class 2 | 868.5120 | 2025-11-26 |
| LBM | Porous Polyethylene Ossicular Replacement | Ear, Nose, Throat | Class 2 | 874.3450 | 2025-11-25 |
| EYY | Drape, Urological, Disposable | General, Plastic Surgery | Class 2 | 878.4370 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2025-11-25 |
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | Class 2 | 870.2850 | 2025-11-24 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2025-11-26 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| LJH | System, Irrigation, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-01-08 |
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2025-11-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2025-11-25 |
| HMT | Drape, Patient, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2026-04-24 |
| GDT | Staple, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4760 | 2025-11-26 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-03-30 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-25 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2025-11-25 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2025-11-24 |
| POE | Extended Depth Of Focus Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2025-11-24 |
| MJP | Lens, Intraocular, Toric Optics | Ophthalmic | Class 3 | 886.3600 | 2025-11-24 |
| MFK | Lens, Multifocal Intraocular | Ophthalmic | Class 3 | 886.3600 | 2025-11-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-26 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2025-11-26 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2025-11-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2025-11-26 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-04-24 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-11-24 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010421104 | STERIS TOMOE SINGAPORE PTE LTD | Singapore South West, SG |
| 3009882464 | Synergy Health AST, LLC | Saxonburg, PA, US |
| 3007738736 | Synergy Health AST, SRL | Alajuela, CR |
| 2030598 | Synergy Health AST, LLC | SAN DIEGO, CA, US |
| 3012102437 | Synergy Health AST, LLC | Petaluma, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K880323 | Medtronic Vascular | MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR | 1988-03-22 |
| K913718 | Abbott Laboratories | PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED | 1991-10-30 |
| K840616 | Advanced Bio Systems, Inc. | MINI-PUMP U-100 | 1984-03-30 |
| K850183 | Deltec Systems, Inc. | CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M | 1985-03-13 |
| K981246 | Integra Neurocare, LLC | BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) | 1999-05-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2011 | Baxter Healthcare Corp. Rt. | 2 | Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161. |
| Z-0002-2011 | Baxter Healthcare Corp. Rt. | 2 | Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163. |
| Z-0005-2025 | Zyno Medical LLC | 2 | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF;
Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z |
| Z-0006-2011 | CareFusion Corporation | 2 | CareFusion Alaris PC Unit Model 8015 (formerly Medley
PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December
20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems. |
| Z-0007-2012 | B Braun Medical, Inc | 2 | Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES
B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006
The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3017528618 | ATRILITY MEDICAL, INC. | Madison, WI, US |
| 3017619000 | SHENZHEN REDY-MED TECHNOLOGY CO., LTD. | Shenzhen Guangdong, CN |
| 2939520 | VOLCANO CORPORATION | Rancho Cordova, CA, US |
| 3004859241 | BOSTON SCIENTIFIC CORPORATION | La Aurora Heredia, CR |
| 3008253300 | Kimball Solutions Jasper, Inc. | Jasper, IN, US |
3017636737 when referencing this establishment in official correspondence.