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A-Med Systems, Inc.

US

Last updated May 23, 2026

What A-Med Systems, Inc. makes

A-Med Systems, Inc. makes vascular cannulas and centrifugal blood pumps, including models such as the A-MED Vascular Cannula (V24 series), Large Centrifugal Blood Pump (CP-2), Heparin Coated Miniature Centrifugal Bypass Pump System (CP-1H), and A-Miniature Centrifugal Blood Pump System (CPB 2000).

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does A-Med Systems, Inc. make?

A-Med Systems, Inc. makes vascular cannulas and centrifugal blood pumps, including specific models such as the A-MED Vascular Cannula (V24 series), Large Centrifugal Blood Pump (CP-2), Heparin Coated Miniature Centrifugal Bypass Pump System (CP-1H), and A-Miniature Centrifugal Blood Pump System (CPB 2000).

Where is A-Med Systems, Inc. based?

A-Med Systems, Inc. is based in the United States, as indicated by the country field in the device data.

Which regulatory registry lists the devices made by A-Med Systems, Inc.?

The devices made by A-Med Systems, Inc. are listed in the FDA 510(k) registry, as specified in the LISTED IN field of the device data.

How are the devices made by A-Med Systems, Inc. classified?

The devices made by A-Med Systems, Inc. are classified as Class II medical devices, according to the DEVICE CLASSES field in the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (434)

Page 4 of 9
DeviceModel / ReferenceRegistriesClassStatus
ABSORBENT, CO2, Carbolime, BAG, 3 LB. Bag ABSORBENT, CO2, Carbolime - 111202
FDA UDI
Class IActive
PFT Kit B, VBMax35 w/ Blue Foam Nose clip PFT Kit B, VBMax35 - 180115
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1.0" OD, 2.625" L Mouthpiece, 1.0" OD, 2.625" L - 162302
FDA UDI
Class IActive
Disposable Blue PFT Nose Clip with Rubber Pads Disposable Blue PFT Nose Clip with Rubber Pads - 166700
EUDAMEDFDA UDI
Class IActive
Absorbent, C02, Sodalime ABSORBENT, C02, SODALIME - 111400
FDA UDI
Class IActive
PFT Kit E, VBMax30E PFT Kit E, VBMax30E - 189130
FDA UDI
Class IIActive
PFT Kit F, VBMax36E, w/foam Nose Clip PFT Kit F, VBMax36E, w/foam - 189147
FDA UDI
Class IIActive
Mouthpiece, Disposable Flex, 1.035" O.D., 2.625" L Mouthpiece, Disposable Flex, 1.035" O.D., 2.625" L - 163503
FDA UDI
Class IActive
Tubing, Smooth Interior, Hytrel, IMC, 22MM-24" Tubing, Smooth Interior, Hytrel, IMC, 22MM-24" - 253100
FDA UDI
Class IActive
Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod Kit, ViroMax, 24" Tubing - 180013
FDA UDI
Class IIActive
Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue Depressing Breathebite Mouthpiece - 164954
FDA UDI
Class IActive
Mouthpiece, Disposable, 1-3/16" O.D., 2.625" L Mouthpiece, 1-3/16" O.D., 2.625" L - 162602
FDA UDI
Class IActive
Flow Tube, Easy One Air, Disposable Flow Tube, Easy One Air - 165760
FDA UDI
Class IActive
Column, Ascarite, Desiccator, Disposable Column, Ascarite, Desiccator - 152906
FDA UDI
Class IActive
PFT Kit B, 30mm Kit with Blue Foam Nose Clip PFT Kit B, 30mm - 181115
FDA UDI
Class IIActive
Mouthpiece, Disposable For SP-150 Sensor Mouthpiece, Disposable For SP-150 Sensor - 165700
FDA UDI
Class IActive
Mouthpiece, Disposable, One-Way Valve Mouthpiece, One-Way Valve - 161520
FDA UDI
Class IActive
VBMax31E VBMax31E - Cosmed 146733
FDA UDI
Class IIActive
Tubing, 1.125" I.D., 1 1/8" - 1 1/8" Fittings, 15" L Tubing, 1.125" I.D., 1 1/8" - 1 1/8" Fittings,15" L - 274215
FDA UDI
Class IActive
Mouthpiece, Reusable, Blue Thermoplastic 7/8" I.D. Mouthpiece, Reusable 7/8" I.D. - 164500
EUDAMEDFDA UDI
Class IActive
VBMax36 VBMax36 - 156607
FDA UDI
Class IIActive
Kit, Mir Disposable Turbine & Vbmax30e KIT, MIR DISPOSABLE TURBINE & VBMAX30E
FDA UDI
Class IIActive
Syringe, Calibration, Adj. Vol., Aluminum, Plain Blue, No Logo Syringe, Calibration, Adj. Vol., Aluminum, Plain Blue, No Logo
FDA UDI
Class IActive
Tubing, Smooth Interior, Hytrel, IMC, 22MM-12" Tubing, Smooth Interior, Hytrel, IMC, 22MM-12" - 253000
FDA UDI
Class IActive
Adapter, Plastic, 2" To 1624 Mouthpiece Adapter, 2" To 1624 Mouthpiece - 114600
FDA UDI
Class IActive
PFT Kit F, VBMax 36E PFT Kit F, VBMax 36E - 189196
FDA UDI
Class IIActive
PFT Kit I, VBMax 34s with Nose Clip and Mouthpiece PFT Kit I - 187114
FDA UDI
Class IIActive
HydroMax HMEF HydroMax HMEF - 158250
FDA UDI
Class IIActive
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 10.5" L Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 10.5" L - 277010
FDA UDI
Class IActive
Noseclip, Disposable , Blue, Rubber Pad Noseclip, Blue, Rubber Pad - 166910
EUDAMEDFDA UDI
Class IActive
Mouthpiece, Disposable, 1.0" OD, 2.625" L Mouthpiece, 1.0" OD, 2.625" L - 162300
FDA UDI
Class IActive
Mask, Face, Large Adult, with Valve Mask, Face, Large Adult, with Valve - 167600
FDA UDI
Class IActive
Chart, X-Ref Godart Statham 13641, 11.75" x 60' Chart, X-Ref Godart Statham 13641 - 135600
FDA UDI
Class IActive
Tubing, Smooth Interior, Hytrel, IMC, 22MM-36" Tubing, Smooth Interior, Hytrel, IMC, 22MM-36" - 253200
FDA UDI
Class IActive
PFT KIT, ADInstruments Custom PFT KIT, ADInstruments Custom - 180005
FDA UDI
Class IIActive
Bag, Breathing, 1-Liter Latex Free Bag, Breathing, 1-Liter Latex Free - 116101
FDA UDI
Class IActive
VBMax VBMax30 - 156304
FDA UDI
Class IIActive
Tubing, Smooth Interior, Disposable Tubing, Smooth Interior, Disposable, 22MM-72" - 243803
FDA UDI
Class IActive
Nebulizer, Hand Held, Tee Adapter, 84" Tube Nebulizer, Hand Held, Tee Adapter, 84" Tube - 166100
FDA UDI
Class IActive
VBMax28e, PF Testing Filter Labeled DR Burton VBMax28e, DR Burton - VBMax28e
FDA UDI
Class IIActive
VBMax35 VBMax35 - 156508
FDA UDI
Class IIActive
Syringe, Calibration, 3 Liter, Aluminum, SDI Diagnostics Syringe, Calibration, 3 Liter, Aluminum, SDI Diagnostics
FDA UDI
Class IActive
VBMax31 VBMax31 - 156713
FDA UDI
Class IIActive
Nasal Cannula, Non-Flare, Non-Crush Resistant Nasal Cannula - 125000
FDA UDI
Class IActive
Mouthpiece, Disposable, 1.0" OD Mouthpiece, Disposable, 1.0" OD - 162323
FDA UDI
Class IActive
Tubing, 1.125" I.D., 7/8"-1 3/8" Fittings, 33" L Tubing, 1.125" I.D., 7/8"-1 3/8" Fittings, 33" L - 273900
FDA UDI
Class IActive
PFT Kit F PFT Kit F - 189180
FDA UDI
Class IIActive
22mm Adapter 22m/15f x 22m / 18f 22mm Adapter 22m/15f x 22m / 18f - 153600
FDA UDI
Class IActive
VBMax VBMax36 - 156600
FDA UDI
Class IIActive
VBMax35 VBMax35 - 156521
FDA UDI
Class IIActive

Related Companies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Aug 10, 2018Z-0120-2019—terminated

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Mar 31, 2010Z-0308-2012—terminated

Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.