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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 2 of 9
DeviceModel / ReferenceRegistriesClassStatus
PFT Kit J, VBMax36S PFT Kit J, VBMax36S - 187196
FDA UDI
Class IIActive
Nebulizer, Hand Held, Tee Adapter Nebulizer, Hand Held, Tee Adapter - 166205
FDA UDI
Class IActive
VBMax36E, PF Testing Filter VBMax36E, PF Testing Filter - 146604
FDA UDI
Class IIActive
VBMax30S VBMax30S - 136307
FDA UDI
Class IIActive
VBMax33 VBMax33 - 156416
FDA UDI
Class IIActive
Kit, Reusable Turbine With Mouthpiece, For MIR SmartOne Kit, Reusable Turbine With Mouthpiece - 180001
FDA UDI
Class IActive
Column, Desiccator, Disposable, 7 In Column, Desiccator, Disposable, 7 In
FDA UDI
Class IActive
PFT Kit F, 35mm e-Series Kit Case PFT Kit F, 35mm e-Series Kit - 189144
FDA UDI
Class IIActive
Flow Sensor, Smart Sense Flow Sensor, Smart Sense - 165725
FDA UDI
Class IActive
VBMax VBMax34S - 136416
FDA UDI
Class IIActive
Chart, X-Ref Puritan Bennett 089028 Chart, X-Ref Puritan Bennett 089028 - 141000
FDA UDI
Class IActive
Pulmonary Sample Kit, Disposable Rubber Mouthpiece Disposable Rubber Mouthpiece Sample Kit - 180049
FDA UDI
Class IActive
VBMax VBMax33 - 156400
FDA UDI
Class IIActive
Mouthpiece, Disposable Flex, 1-1/16" OD, 2.625" L Mouthpiece, Disposable Flex, 1-1/16" OD, 2.625" L - 162403
FDA UDI
Class IActive
VBMax VBMax30 - 156300
FDA UDI
Class IIActive
VBMax VBMax35 - 156511
FDA UDI
Class IIActive
Mouthseal, Disposable, Blue Thermoplastic IPPB Mouthseal,Blue Thermoplastic IPPB - 165200
FDA UDI
Class IActive
Mask, Face, Neonate, w/o Valve Mask, Face, Neonate, w/o Valve - 167500
FDA UDI
Class IActive
Chart, X-Ref Spirotech S010-06, 8.5" x 11", Grn Chart, X-Ref Spirotech S010-06 - 133800
FDA UDI
Class IActive
Optichamber Diamond w/ Small, Lite Touch VHC Mask Optichamber Diamond w/ Small, Lite Touch VHC Mask - 166402
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1-1/4" O.D., 2.625" L Mouthpiece,1-1/4" O.D., 2.625" L - 163000
FDA UDI
Class IActive
PFT Kit F, VBMax34E PFT Kit F, VBMax34E - 189142
FDA UDI
Class IIActive
Adapter, Tube, Blue Thermoplastic Rubber, 1 3/8 TO 1 Adapter, Reusable, 1 3/8 TO 1 - 113500
FDA UDI
Class IActive
Mask, Face, Small Adult, w/Valve Mask, Face, Small Adult, w/Valve - 167901
FDA UDI
Class IActive
Vbmax34, Disposable Pf Testing Filter VBMAX34 - 156400
FDA UDI
Class IIActive
Column, Desiccator, Disposable, 7 In Column, Desiccator, Disposable, 7 In - 153106
FDA UDI
Class IActive
Chart, X-Ref Jones JP1006A 7.4 L, Press Type, 5x9 Chart, X-Ref Jones JP1006A 7.4 L - 138000
FDA UDI
Class IActive
PFT Kit C, 30MM OD Filter PFT Kit C, 30MM OD Filter- 181103
FDA UDI
Class IIActive
Adapter , 22 MM O.D. TO 15 MM I.D. Adapter , 22 MM O.D. TO 15 MM I.D. - 153700
FDA UDI
Class IActive
Mouthpiece, Reusable, Blue Thermoplastic 7/8" - 1" I.D. Mouthpiece, Reusable 7/8" - 1" I.D. - 164600
EUDAMEDFDA UDI
Class IActive
Column, Ascarite Desiccator, Disposable Column, Ascarite Desiccator - 153500
FDA UDI
Class IActive
Adapter, Syringe to NDD Syringe Adapter 5030-2 Adapter, Syringe to NDD Syringe Adapter 5030-2
FDA UDI
Class IActive
VBMax30 VBMax30 - 156302
FDA UDI
Class IIActive
Syringe, Calibration, Adj. Vol. Syringe, Calibration, Adj. Vol. - 192814
FDA UDI
Class IActive
VBMax VBMax34E - 146418
FDA UDI
Class IIActive
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 30" L Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 30" L - 277800
FDA UDI
Class IActive
Mouthpiece, Disposable, 1.058" O.D., 2.625" L Mouthpiece,1.058" O.D., 2.625" L - 163802
FDA UDI
Class IActive
PFT Kit J, VBMax 30s w/ Foam Nose Clip PFT Kit J, VBMax 30s - 187180
FDA UDI
Class IIActive
Syringe, Calibration, 3 Liter, Aluminum, Eliptical Cap Syringe, Calibration, 3 Liter, Aluminum, Eliptical - 192900
FDA UDI
Class IActive
Chart, X-Ref Collins Survey 22035, 9x19.625, Gum Chart, X-Ref Collins Survey 22035 - 133300
FDA UDI
Class IActive
Adapter, Morgan Scientific To VBMax30 Adapter - 115540
FDA UDI
Class IActive
VBMax VBMax28S - 136900
FDA UDI
Class IIActive
PFT Kit I, VBMax31S PFT Kit I, VBMax31S - 187121
FDA UDI
Class IIActive
Small Adapter, VBMAX35 to Collins PFT Machines Adapter, VBMax35 to Collins Mach. - 115523
FDA UDI
Class IActive
Mouthpiece, Disposable, 1.035" O.D., 2.625" L Mouthpiece, 1.035" O.D., 2.625" L - 163502
FDA UDI
Class IActive
Tubing, Smooth Interior, Disposable, 22MM-60" Tubing, Smooth Interior, Disposable, 22MM-60" - 243703
FDA UDI
Class IActive
Nut and Nipple, Swivel, White (Vacuum) Nut and Nipple (Vacuum) - 159300
FDA UDI
Class IActive
Pulmonary Function Test Kit J Pulmonary Function Test Kit J - 187194
FDA UDI
Class IIActive
Tubing, 1.125" I.D., 7/8"-1 1/8" Fittings, 34" L Tubing, 1.125" I.D., 7/8"-1 1/8" Fittings, 34" L - 273800
FDA UDI
Class IActive
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 40" L Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 40" L - 278600
FDA UDI
Class IActive

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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.