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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 7 of 9
DeviceModel / ReferenceRegistriesClassStatus
VBMax VBMax28S - 136907
FDA UDI
Class IIActive
PFT Kit A PFT Kit A, Disposable, 30 MM O.D. - 181111
FDA UDI
Class IIActive
Flow Tube, Easy One Air, Disposable Flow Tube, Easy One Air, - 165750
FDA UDI
Class IActive
VBMax28, Disposable PF Testing Filter VBMax28 - 156900
FDA UDI
Class IIActive
Mouthpiece, Disposable, .900"OD, 2.50" L Assess Small Mouthpiece, Disposable, .900"OD, 2.50" L - 168300
FDA UDI
Class IActive
PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip - 183112
FDA UDI
Class IIActive
PFT Kit I PFT Kit I, VBMax 36S, w/ White Foam Noseclips - 187126
FDA UDI
Class IIActive
VBMax30S, PF Testing Filter Labeled DR Burton VBMax30S - 136304
FDA UDI
Class IIActive
PFT Kit A, 33 MM PFT Kit A, 33 MM - 183101
FDA UDI
Class IIActive
Tubing, Smooth Interior, Disposable, 1.98"X39" Tubing, Smooth Interior, Disposable, 1.98"X39" - 245200
FDA UDI
Class IActive
Chart, X-Ref Breon 2206, 6.625" x 8", Green Chart, X-Ref Breon 2206 - 131200
FDA UDI
Class IActive
VBMax34, PF Testing Filter Labeled DR Burton VBMax34, PF Testing Filter - 156404
FDA UDI
Class IIActive
Chart, X-Ref Collins Apex 22023 11" x 19.625", Grn Chart, X-Ref Collins Apex 22023 - 133500
FDA UDI
Class IActive
PFT Kit C, 36 MM O.D. PFT Kit C, 36 MM O.D. - 184103
FDA UDI
Class IIActive
PFT Kit A, 48 MM O.D. PFT Kit A, 48 MM O.D. - 188101
FDA UDI
Class IIActive
VBMax34S VBMax34S - 136407
FDA UDI
Class IIActive
Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style Disposable Mouthpiece, Bite Block Style - 164904
FDA UDI
Class IActive
Disposable Thermoplastic Mouthpiece Disposable Thermoplastic Mouthpiece - 164900
EUDAMEDFDA UDI
Class IActive
Pft Kit A, 36 Mm O.d. PFT KIT A, 36 MM O.D. - 184101
FDA UDI
Class IIActive
VBMax34E, PF Testing Filter Labeled DR Burton VBMax34E - 146404
FDA UDI
Class IIActive
Mouthpiece, Disposable Lip Style, White Mouthpiece, Disposable Lip Style, White - 164800
FDA UDI
Class IActive
Mouthpiece, Disposable, Flow Sensor Mouthpiece, Disposable, Flow Sensor - 165900
FDA UDI
Class IActive
Chart Paper, Thermal, for Spirolab Spirometers Chart Paper, Thermal, for Spirolab - 140700
FDA UDI
Class IActive
PFT Kit F, VBMax28S, w/ Rubber Mouthpiece PFT Kit F, VBMax28S - 187178
FDA UDI
Class IIActive
Syringe, Calibration, 3 Liter, Aluminum Syringe, Calibration, 3 Liter, Aluminum - 192704
FDA UDI
Class IActive
Pulmonary Function Test Kit F Pulmonary Function Test Kit F, 189174
FDA UDI
Class IIActive
ViroMax ViroMax - 156200
FDA UDI
Class IIActive
Tubing, 1.125" I.D., 1 1/8"-1 3/8" Fittings, 28" L Tubing, 1.125" I.D., 1 1/8"-1 3/8" Fittings, 28" L - 274600
FDA UDI
Class IActive
PFT Kit E, VBMax35E PFT Kit E, VBMax35E - 189165
FDA UDI
Class IIActive
PFT KIT F, VBMax36E, W/BLUE NOSE CLIP PFT KIT F, VBMax36E, W/BLUE NOSE CLIP - 189176
FDA UDI
Class IIActive
Mouthseal, Disposable, White Thermoplastic IPPB Mouthseal, White Thermoplastic IPPB - 165400
FDA UDI
Class IActive
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 34" L Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 34" L - 278200
FDA UDI
Class IActive
Syringe, Calibration, Adj. Vol., Aluminum, MGC Diagnostics Logo Syringe, Calibration, Adj. Vol., Aluminum, MGC Diagnostics Logo
FDA UDI
Class IActive
Filter, Clear, Disposable, Viral/ Bacterial Filter, Clear, Disposable,Viral/ Bacterial - 155200
FDA UDI
Class IIActive
VBMax VBMax35 - 156516
FDA UDI
Class IIActive
Disposable Blue PFT Nose Clip with Rubber Pads Disposable Blue PFT Nose Clip - 166704
FDA UDI
Class IActive
ndd Spirette Breathing Tube ndd Spirette Breathing Tube - 165850
FDA UDI
Class IActive
Mouthpiece, Disposable Flex, 3/4" OD, 2.625" L Mouthpiece,Flex, 3/4" OD, 2.625" L - 162103
FDA UDI
Class IActive
PFT Kit C PFT Kit C - 180053
FDA UDI
Class IIActive
VBMax VBMax35E - 146500
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1.01 OD, 2.625" L Mouthpiece,1.01 OD, 2.625" L - 163300
FDA UDI
Class IActive
VBMax35 E, Disposable PF Testing Filter VBMax35 E - 146504
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1.058" O.D., 2.625" L Mouthpiece,1.058" O.D., 2.625" L - 163800
FDA UDI
Class IActive
Column, Ascarite, Desiccator, Disposable Column, Ascarite, Desiccator - 152900
FDA UDI
Class IActive
VBMax VBMax30L - 156370
FDA UDI
Class IIActive
Breathbite Mouthpiece, Disposable , Tongue Depressing Breathbite Mouthpiece - 164950
EUDAMEDFDA UDI
Class IActive
Mouthpiece, Disposable, 1.035" O.D., 2.625" Length Mouthpiece,1.035" O.D., 2.625" L - 163500
FDA UDI
Class IActive
Coupler, 22 MM O.D. TO 15 MM O.D. Coupler, 22 MM O.D. TO 15 MM O.D. - 153800
FDA UDI
Class IActive
PFT Kit I, Disposable, VBMax31S, W/ Blue Rubber Nose Clips PFT Kit I - 187111
FDA UDI
Class IIActive
Nut and Nipple, Swivel, Green (Oxygen) Nut and Nipple, Swivel - 155400
FDA UDI
Class IActive

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.