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A-Med Systems, Inc.

Last updated May 23, 2026

Information

Country: US
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Catalogue (434)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
PFT KIT F, DISPOSABLE, VBMax34S	PFT KIT F, VBMax34S - 187143	FDA UDI	Class II	Active
Kit, MIR Disposable Turbine & VBMax30E	Kit, MIR Disposable Turbine & VBMax30E	FDA UDI	Class II	Active
Syringe, Calibration, Adj. Vol., Aluminum, A-M Systems	Syringe, Calibration, Adj. Vol., Aluminum, A-M Systems	FDA UDI	Class I	Active
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 8.5" L	Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 8.5" L - 277000	FDA UDI	Class I	Active
VBMax	VBMax28E - 146907	FDA UDI	Class II	Active
VBMax	VBMax30E - 146300	FDA UDI	Class II	Active
PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900	PFT Kit I, VBMax36S - 187266	FDA UDI	Class II	Active
Nasal Cannula Disposable 7Ft	Nasal Cannula Disposable 7Ft - 125200	FDA UDI	Class I	Active
PFT Kit A, Disposable, 48MM OD	PFT Kit A, Disposable, 48MM OD - 188413	FDA UDI	Class II	Active
VBMax	VBMax30 - 156311	FDA UDI	Class II	Active
Bag, Breathing, 3-Liter Latex Free	Bag, Breathing, 3-Liter Latex Free - 116301	FDA UDI	Class I	Active
Tubing, 1.125" I.D., 1 1/8" - 1 1/8" Fittings, 36" L	Tubing, 1.125" I.D., 1 1/8" - 1 1/8" Fittings,36" L - 274200	FDA UDI	Class I	Active
PFT Kit I, VBMax35S, w/ White Foam Nose Clips	PFT Kit I, VBMax35S - 187125	FDA UDI	Class II	Active
PFT Kit E, VBMax31E	Kit E, VBMax31E, 189111	FDA UDI	Class II	Active
3L Calibration Syringe	3L Calibration Syringe - 192700	FDA UDI	Class I	Active
PFT Kit, Disposable, AstraGuard / Noseclip	PFT Kit, Disposable, AstraGuard and Noseclip - 180008	FDA UDI	Class II	Active
Tubing, 1.125" I.D., 7/8"-1 3/8" Fittings, 36" L	Tubing, 1.125" I.D., 7/8"-1 3/8" Fittings, 36" L - 274000	FDA UDI	Class I	Active
PFT Kit B, 35MM	PFT Kit B, 35MM - 180112	FDA UDI	Class II	Active
Adapter, Syringe To Spirolab & SBG Spirometer	Adapter - 115600	FDA UDI	Class I	Active
Mask, Face, Medium Adult	Mask, Face, Medium Adult - 167100	FDA UDI	Class I	Active
Adapter, NDD Syringe Adapter 5030-2	NDD Syringe Adapter 5030-2, 115616	FDA UDI	Class I	Active
Chart, X-Ref Puritan Bennett 089069	Chart, X-Ref Puritan Bennett 089069 - 140900	FDA UDI	Class I	Active
Mouthpiece, Disposable, .875"OD, 2.50" L	Mouthpiece, Disposable, .875"OD, 2.50" L - 168382	FDA UDI	Class I	Active
Tubing, End Fitting, 1 3/8" I.D. TO 1 1/8" Tubing	Tubing, End Fitting, 1 3/8" I.D. TO 1 1/8" Tubing - 270400	FDA UDI	Class I	Active
Nut and Nipple, Swivel, B&W (Nitrogen)	Nut and Nipple, (Nitrogen) - 159500	FDA UDI	Class I	Active
Chart, X-Ref Puritan Bennett 004057	Chart, X-Ref Puritan Bennett 004057 - 141100	FDA UDI	Class I	Active
PFT Kit E, VBMax28E	PFT Kit E, VBMax28E - 189128	FDA UDI	Class II	Active
VBMax34S	VBMax34S - 136408	FDA UDI	Class II	Active
3 Liter Aluminum Calibration Syringe	3 Liter Aluminum Calibration Syringe - 192717	FDA UDI	Class I	Active
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 20" L	Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 20" L - 277400	FDA UDI	Class I	Active
VBMax36	VBMax36 - 156616	FDA UDI	Class II	Active
Adapter, Tube, Sample Pack	Adapter, Tube, Sample Pack - 113300	FDA UDI	Class I	Active
PFT Kit G, VBMax 34E	PFT Kit G, VBMax 34E - 189153	FDA UDI	Class II	Active
Mouthpiece, Disposable, .900"OD, 2.50" L	Mouthpiece, Disposable, .900"OD, 2.50" L - 168302	FDA UDI	Class I	Active
Noseclip, Disposable , White, Foam Pad	Noseclip, Disposable , White, Foam Pad	FDA UDI	Class I	Active
Mouthpiece, Reusable, Blue Thermoplastic 1 1/4" I.D.	Mouthpiece, Reusable 1 1/4" I.D. - 164200	EUDAMEDFDA UDI	Class I	Active
Mouthpiece, Disposable , White, Thermoplastic	Mouthpiece, Disposable , White, Thermoplastic - 164901	FDA UDI	Class I	Active
PFT Kit E, VBMax28E	PFT Kit E, VBMax28E - 189108	FDA UDI	Class II	Active
Syringe, Calibration, Adj. Vol., Aluminum,	192803 - CHS	FDA UDI	Class I	Active
VBMax	VBMax30S - 136300	FDA UDI	Class II	Active
VBMax	VBMax35S - 136500	FDA UDI	Class II	Active
Adapter, Rubber, 1 3/8 To 1 1/8	ADAPTER, RUBBER, 1 3/8 TO 1 1/8 - 113800	FDA UDI	Class I	Active
Mouthpiece, Disposable, 1-3/8" O.D., 2.625" L	Mouthpiece, 1-3/8" O.D., 2.625" L - 162802	FDA UDI	Class I	Active
VBMax	VBMax34S - 136400	FDA UDI	Class II	Active
Mouthpiece, Disposable, 1.02" ID, 2.55" Length	Mouthpiece, 1.02" ID, 2.55" Lngth - 161300	FDA UDI	Class I	Active
VBMax	VBMax30 - 156310	FDA UDI	Class II	Active
PFT Kit F, VBMax36S w/ Foam Nose Clip	PFT Kit F, VBMax36S - 187147	FDA UDI	Class II	Active
Adapter, Tube, Blue Plastic, 1 3/8"	Adapter, Tube, Blue Plastic, 1 3/8" - 114800	FDA UDI	Class I	Active
VBMax	VBMax48 - 156811	FDA UDI	Class II	Active
Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8	Adapter, Plexiglas, 1 1/2 TO 1 3/8 - 114000	FDA UDI	Class I	Active

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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.

Date	Recall No.	Class	Status	Reason
Aug 10, 2018	Z-0120-2019	—	terminated	Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
Mar 31, 2010	Z-0308-2012	—	terminated	Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.