FDA Device Registration & Listing · Bridgetown Saint Michael, BB · Registration 3000268902
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-02-26 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2025-02-26 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2025-04-01 |
| FOD | Device, Occlusion, Umbilical | General Hospital | Class 1 | 880.5950 | 2025-04-01 |
| KPE | Container, I.V. | General Hospital | Class 2 | 880.5025 | 2021-03-16 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2023-07-28 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2024-05-03 |
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | Class 2 | 878.4580 | 2024-11-06 |
| KZF | Device, Medical Examination, Ac Powered | General Hospital | Class 1 | 880.6320 | 2018-12-27 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2011-04-29 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2023-09-21 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2024-05-03 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2023-08-14 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2011-11-02 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2023-03-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-11-06 |
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-12-27 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2023-06-07 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2011-04-29 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-30 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2011-04-29 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2024-11-06 |
| KDQ | Bottle, Collection, Vacuum | General Hospital | Class 2 | 880.6740 | 2019-08-15 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | Class 1 | 866.2390 | 2025-08-05 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2026-05-05 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2012-03-02 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-02-26 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2018-12-27 |
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | Class 2 | 886.1570 | 2018-12-27 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2026-02-25 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2022-01-14 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2024-03-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-12-27 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2023-06-06 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 2021-12-20 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2011-04-29 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-01-02 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2026-03-26 |
| EZR | Cement, Stomal Appliance, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2018-02-07 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2019-12-17 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2022-07-06 |
| MLR | Sterilizer, Chemical | General Hospital | Class 2 | 880.6860 | 2023-04-15 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2026-04-29 |
| DWM | Apparatus, Suction, Patient Care | Cardiovascular | Class 2 | 870.5050 | 2017-09-24 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2018-09-21 |
| EYB | Catheter, Ureteral, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-11-06 |
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | Class 1 | 868.5110 | 2019-04-16 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2026-02-27 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2025-04-01 |
| HXT | Tape, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2012-02-16 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2011-04-29 |
| OHY | Pill Crusher/Cutter | General Hospital | Class 1 | 880.6430 | 2025-03-24 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2012-03-02 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K892118 | Paramount Products, Inc. | NON-STERILE MASKS AND CAPS | 1989-04-20 |
| K041415 | B.Braun Medical, Inc. | EVA TPN CONTAINER | 2004-08-04 |
| K882164 | Arthur Blank & Co., Inc. | FLOSS CARD | 1988-06-10 |
| K150445 | Asahi Intecc Co., Ltd. | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | 2015-06-30 |
| K082922 | Lake Region Mfg., Inc. | FREEWAY AND RAILRUNNER GUIDEWIRES | 2008-12-09 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2020 | The Metrix Company | 2 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. |
| Z-0002-2020 | The Metrix Company | 2 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. |
| Z-0003-2020 | The Metrix Company | 2 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. |
| Z-0004-2020 | The Metrix Company | 2 | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. |
| Z-0005-2020 | The Metrix Company | 2 | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3042245424 | Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone | Ismailia Al Isma'iliyah, EG |
| 3016678045 | Schneider ASR B.V. | Rotterdam-Albrandswaard Zuid-Holland, NL |
| 8030672 | Cirpro de Delicias S. de R.L. de C.V. | DELICIAS Chihuahua, MX |
| 1527607 | SRI Healthcare, LLC | MASON, OH, US |
| 3027977504 | MEDLINE CHILE SPA | Pudahuel Region Metropolitana, CL |
3000268902 when referencing this establishment in official correspondence.