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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 5 of 9
DeviceModel / ReferenceRegistriesClassStatus
VBMax VBMax35S - 136507
FDA UDI
Class IIActive
Pulmonary Function Test Kit E PFT Kit E, DR Burton - 189042
FDA UDI
Class IIActive
Nut and Nipple, Swivel, Yellow (Air) Nut and Nipple, (Air) - 159200
FDA UDI
Class IActive
VBMax34S, PF Testing Filter Labeled DR Burton VBMax34S - 136404
FDA UDI
Class IIActive
Tubing, Smooth Interior, Disposable, 22MM-6" Tubing, Smooth Interior, Disposable, 22MM-6" - 242903
FDA UDI
Class IActive
Syringe, Calibration, 3 Liter, Aluminum, Plain White, No Logo Syringe, Calibration, 3 Liter, Aluminum, Plain White, No Logo - 192713
FDA UDI
Class IActive
PFT Kit E, 36mm e-Series Kit PFT Kit E, 36mm Kit - 189136
FDA UDI
Class IIActive
Tubing, 1.125" I.D., 7/8"-7/8" Fittings, 5.5" L Tubing, 1.125" I.D., 7/8"-7/8" Fittings, 5.5" L - 273000
FDA UDI
Class IActive
Syringe, Calibration, 3 Liter, Aluminum, w/ Modified Front Cap Syringe, Calibration, 3 Liter, Aluminum - 192701
FDA UDI
Class IActive
Chart Paper Thermal For PB900 4 9/32" x2 1/4" Chart Paper Thermal For PB900 - 140800
FDA UDI
Class IActive
VBMax34E, Disposable PF Testing Filter VBMax34E - 146472
FDA UDI
Class IIActive
VBMax30L VBMax30L - 156377
FDA UDI
Class IIActive
Tubing, Smooth Interior, Hytrel, IMC, 22MM-14" Tubing, Smooth Interior, Hytrel, IMC, 22MM-14" - 252800
FDA UDI
Class IActive
Mouthseal, Disposable, Blue Thermoplastic Rubber Mouthseal,Blue Thermoplastic Rubber - 165100
FDA UDI
Class IActive
PFT Nose Clip with Foam Pads PFT Nose Clip with Foam Pads
FDA UDI
Class IActive
Tubing, 1.125" I.D., 7/8"-7/8" Fittings, 34" L Tubing, 1.125" I.D., 7/8"-7/8" Fittings, 34" L - 273400
FDA UDI
Class IActive
Chart, X-Ref Puritan Bennett 4020 Chart, X-Ref Puritan Bennett 4020 - 141200
FDA UDI
Class IActive
VBMax34E VBMax34E - 146407
FDA UDI
Class IIActive
Adapter, Syringe to SDI Astra Adapter, Syringe to SDI Astra - 115601
FDA UDI
Class IActive
PFT Kit E, VBMax36E PFT Kit E, VBMax36E - 189139
FDA UDI
Class IIActive
PFT KIT F, VBMax36S w/ Rubber Nose Clips PFT KIT F, VBMax36S - 187146
FDA UDI
Class IIActive
VBMax48, Disposable PF Testing Filter VBMax 48 - 156804
FDA UDI
Class IIActive
Mouthpiece, Disposable, Vitalor Mouthpiece, Disposable, Vitalor - 163600
FDA UDI
Class IActive
Column, Sodasorb Disposable, 5.75" L Column, Sodasorb Disposable, 5.75" L - 152600
FDA UDI
Class IActive
Nut and Nipple, Swivel, Blue (Nitrous Oxide) Nut and Nipple (Nitrous Oxide) - 159400
FDA UDI
Class IActive
Optichamber Diamond Optichamber Diamond - 166401
FDA UDI
Class IIActive
Pulmonary Function Test Kit B, VBMax 48 MM Pulmonary Function Test Kit B, Disposable, VBMax 48 MM - 188414
FDA UDI
Class IIActive
Mouthpiece, Disposable, White, Thermoplastic Mouthpiece, White, Thermoplastic - 164910
FDA UDI
Class IActive
Noseclip, Disposable , White, Foam Pad White Foam Pad Noseclip - 166525
FDA UDI
Class IActive
PFT Kit F, Disposable, VBMax28E PFT Kit F - 189188
FDA UDI
Class IIActive
VBMax VBMax35 - 156501
FDA UDI
Class IIActive
Nebulizer, Side Stream, Re-Usable Nebulizer, Side Stream, Re-Usable - 166112
FDA UDI
Class IActive
PFT Kit G, VBMax36E PFT Kit G, VBMax36E - 189156
FDA UDI
Class IIActive
VBMax28e VBMax28E - 146918
FDA UDI
Class IIActive
Chart Paper, Thermal, for Cosmed Pony FX Spirometer Chart Paper, Thermal - 140600
FDA UDI
Class IActive
PFT Kit J, VBMax35s PFT Kit J, VBMax35s - 187175
FDA UDI
Class IIActive
VBMax VBMax31 - 156700
FDA UDI
Class IIActive
VBMax35E VBMax35E - 146516
FDA UDI
Class IIActive
Syringe, Calibration, 3 Liter, Aluminum, Plain Blue, No Logo Syringe, Calibration, 3 Liter, Aluminum - 192702
FDA UDI
Class IActive
Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton Disposable White PFT Nose Clip with Rubber Pads - 166004
FDA UDI
Class IActive
PFT Kit B, 35MM PFT Kit B, 35MM - 180113
FDA UDI
Class IIActive
Column, Desiccator, Disposable, 3.5 In Column, Desiccator, Disposable, 3.5 In - 153300
FDA UDI
Class IActive
Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow Meter Mouthpiece, 0.86" OD, 2.00" L - 161902
FDA UDI
Class IActive
Pft Kit A, 30mm Od Filter PFT KIT A, 30MM FILTER - 181101
FDA UDI
Class IIActive
PFT Kit F, VBMax36S PFT Kit F, VBMax36S - 187156
FDA UDI
Class IIActive
Syringe, Calibration, Adj. Vol., Aluminum Adj. Vol., Aluminum Syringe - 192817
FDA UDI
Class IActive
PFT Kit B, Disposable VBMax35 PFT Kit B - 180117
FDA UDI
Class IIActive
Syringe, Calibration, Adj. Vol., Aluminum Syringe, Calibration, Adj. Vol., Aluminum - 192801
FDA UDI
Class IActive
VBMax VBMax35 - 156500
FDA UDI
Class IIActive
VBMax35, PF Testing Filter VBMax35, PF Testing Filter - 156505
FDA UDI
Class IIActive

Related Companies

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Notified Bodies

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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.