Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010291427

FEI Number

3010291427

Entity Name

AvailMed S.A.De C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

C.Industrial Lt.001 Mz.105, No. 20905 Int.A. Col. Cd. Industrial, Tijuana Baja California C.P. 22444, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Flextronics International USA, Inc. (Owner Number: 9006592)

Owner / Operator Contact Address

12455 Research Blvd, Austin, TX 78759, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDRAD INTEGO STERILE DISPOSABLES Ophthalmic Femtosecond Laser Single Use Pack, Model OPO80 FUSION OPO70 Pack FUSION OPO71 DUAL PUMP Pack Optune Sterile Luer Lock-to-Urethral Tip Adapter Mobi, 10 Pack RapidFill Connectors Dispensing Pin Tube Set PEAK PlasmaBlade Suction Coag Model Number PS300-004E Runway Guide Catheter Hemostatic Valve, .115 ID SKU 23245 Y-Connector with modified Tuohy-Borst Adapter, Stretch insertion tool OPOHF20L, 20G High Flow Irrigation Sleeve, Reusable OPOHF21L, 21G High Flow Irrigation Sleeve, Reusable Sealant, Dural CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM InfoVAC Canisters, V.A.C Freedom Canisters LEAD STYLET,MODELS 6505,6506,6507,6508 INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE, INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, 6400, 1001-22 Piton Y-adapter, Piton Tri-adapter Mullins Transseptal Catheter Introducer Sheath and Medtronic Transseptal Catheter Introducer Sheath MODIFICATION TO SCIMED 6F IMPULSE A SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATER ABTHERA Open Abdomen Dressing 034-SKR-421, 034-SKR-420-4 STRYKER PAINPUMP PCA CYSTO-AID 130 CM WIDE Guide Wire Introducer SKU 22290 Guide Wire Accessory Kit SKU 22295 Torque Device SKU 22215; 1003279 Guide Wire Accessory Kit w/115 RHV; SKU 22295-115 Torque Device SKU 22215 Unit, phacofragmentation Impulse Angiographic Catheter Expo Angiographic Catheter SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS V.A.C Y-connector SCIMED IMPULSE ANGIOGRAPHIC CATHETE SCIMED IMPULSE ANGIOGRAPHIC CATHETER OPO39, AMO VitrePure Vitretomy Handpiece VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Everest 20/30 Inflation Device, Everest 20/30 Survival Kit ExactaMix Bag Tube Set Universal Spike HyHub Vial Access Devices REPEATER PUMP II TUBE SETS ActiVAC Canisters Stryker Color Cuff Cylindrical Tourniquet OPOD20L, 20G Laminar Flow Irrigation Sleeve Indeflator Plus 30 SKU 1000183 Priority Pack Plus 30 w/115 RHV; SKU 1000185-115 Priority Pack Plus 30 SKU 1000185 Priority Pack 20/30 w/ CoPilot; SKU 1003327 Guide Wire Accessory Kit w/ CoPilot; SKU 1003330 Copilot BBC Valve SKU 1003331 EXACTAMIX Bag Cap ExactaMed Tip Cap DiscPac Tip Cap Adapter Connector PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool) Priority Pack 20/30 SKU 1000186 Indeflator 20/30 SKU 1000184 Priority Pack 20/30 w/115 RHV; SKU 1000186-115 CATHETER, RETENTION, BARIUM ENEMA WITH BAG, 1001-21, Exacta-I screw cap CATHETER RETENTION BARIUM WITH BAG, Flexi-Tip, 1001-30, 1001-32, 1001-36 Barium Enema Ring, 1001-20 CATHETER RETENTION BARIUM WITH BAG, RTB BULK PACK,1001-1 SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF, 1001-11 Rounded Flex-Tip, 1001-28 CATHETER RETENTION BARIUM WITH BAG, NS TUBING CLAMP, EZEM-848 CATHETER RETENTION BARIUM WITH BAG,AIR BULB INSUFLATOR,1001-37,ONE SHOT CUFF INFLATOR 1001-38, XL MILLER AIRTIP,1001-84 Non Latex, air retention tip, 1001-025 Enema delivery system CATHETER, INTRAVASCULAR, Catheter, percutaneous V390 Cysto Aid, BCC-1001-093 AbThera SensaT.R.A.C. Open Abdomen Dressing, AbThera Advance Open Abdomen Dressing PI's Endopouch Retriever SCIMED EXPO ANGIOGRAPHIC CATHETER Needle Adapter t:slim X2 Insulin Pump with Basal-IQ Technology E-Z-EM Enteroclysis Catheter Set, ET 412 E-Z-EM Enteroclysis Catheter Set Stryker Laparoscope NGP0020, Vitreous Cutter 25G NGP0020, Vitreous Cutter 20G NGP0020, Vitreous Cutter 23G V.A.C Drape, V.A.C Tubing Cap, Sensatrac pad OPOS19L, 19G Laminar Flow Irrigation Sleeve, Reusable OPOS21LD, 21G Laminar Flow Irrigation Sleeve OPOS21L, 21G Laminar Flow Irrigation Sleeve, Reusable OM3452032, OMS Infusion Sleeve, Reusable OPOS20LD, 20G Laminar Flow Irrigation Sleeve OPOS20L, 20G Laminar Flow Irrigation Sleeve, Reusable OM5240011, Aspirant Collection Bag OM3452022, Phacotest Chamber, Reusable Dual Pump Pack, Model OPO73 SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER Rotating Hemostatic Valve SKU 23242 ExactaMix Valve Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2009-10-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2023-04-28
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-05-04
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-09-07
NZK	Stimulator, Low Electric Field, Tumor Treatment	Unknown	Class 3	N/A	2023-12-15
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2026-01-23
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-08-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-11-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-05-13
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-05-28
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-05-04
NQR	Sealant, Dural	Unknown	Class 3	N/A	2017-06-15
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2009-10-22
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-14
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2009-10-22
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2009-10-22
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-05-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2010-11-11
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-08-04
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2009-10-22
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2009-10-22
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2014-01-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-07-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-05-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-05-13
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2009-10-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-01-31
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2009-10-22
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-08-04
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2017-05-04
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2021-03-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2009-10-22
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2022-04-27
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2009-10-21
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-08-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-04-20
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-14
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2011-09-21
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-05-04
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2014-05-13
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2014-05-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2017-01-31
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2016-06-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-12-14
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2014-05-13
FGD	Catheter, Retention, Barium Enema With Bag	Gastroenterology, Urology	Class 2	876.5980	2015-01-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2009-10-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2009-10-21
FNP	Urinal	General Hospital	Class 1	880.6730	2015-07-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-14
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2016-11-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-02-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-08-24
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2017-05-04
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2020-02-25
PQF	Sensor, Glucose, Invasive, Non-Adjunctive	Unknown	Class 3	N/A	2020-02-25
EZK	Catheter, Retention Type	Gastroenterology, Urology	Class 2	876.5980	2009-10-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-10-22
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2017-05-04
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-14
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-05-04
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-02-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-08-09
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2014-05-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2017-01-23
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2017-01-23
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-12-14

Official Correspondent

Chad Ashton

US Agent Details

Chad Ashton Business: FLEXTRONICS INTERNATIONAL USA, INC. Email: chad.ashton@flex.com Phone: (901) 8712423

Related Public Records

Same Entity

Flextronics International USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3008886285	Flextronics International Kft	Budapest, HU
3006126537	FLEXTRONICS INTERNATIONAL GMBH	ALTHOFEN Karnten, AT
3021010223	Flex Precision Plastics Solutions AG	Kussnacht Schwyz, CH
3022473387	Flextronics Medical Molding (Shenzhen) Co., Ltd	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27

Related Recall Records

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.

Similar Registrations

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3005700264	Orbray (Thailand) Co. Ltd.	Muang Lamphun, TH
3005768810	BO-MER PLASTICS	Auburn, NY, US
3008513006	ELIXIR CORPORATION	Suwanee, GA, US
3012337868	InfuSystem Inc.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010291427. Last updated year: 2026. Please use registration number 3010291427 when referencing this establishment in official correspondence.