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ACCUTRON

United States·US-MF-000009363

Last updated September 17, 2026

Information

Country: United States
Address: 1625, W Pinnacle Peak Rd., Phoenix, United States
Website: hu-friedy.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Mark Dammann
EUDAMED SRN: US-MF-000009363
FDA FEI Number: 2020813
DUNS Number: —

Catalogue (646)

Page 10 of 13

Device	Model / Reference	Registries	Class	Status
Surface Q/C Dual Outlet	34076	FDA UDI	Class I	Active
FRU, Cone Ring (Matrx)	26250	FDA UDI	Class I	Unknown
Recessed QC Outlet Vacuum	34011	FDA UDI	Class I	Active
Outlet, Receessed Nitrogen, Diss	34010-D	FDA UDI	Class I	Active
O2 Cannula, 50 Clear Adult, 7' Tubing	33030-50	FDA UDI	Class I	Active
FRU, O2 DISS Y w Valves	27102	FDA UDI	Class I	Active
Directional Y Valve, Belmed	47050-BEL	FDA UDI	Class I	Active
Accutron O2 Q/C Hose _____________FT	34070-CUSTOM	FDA UDI	Class I	Unknown
Schrader Flush Q/C Hose Set 4 Ft.	34668-4	FDA UDI	Class I	Active
Field Verification Kit	44055	FDA UDI	Class I	Active
Ultra DC Oral Surgery Package C	46200-OS	FDA UDI	Class II	Active
Ultra PC% Cabinet Mount Package H, No Shut-offs	36800-NS	FDA UDI	Class II	Active
Surgical Suction Kit, OXQ	34014-OXQ	FDA UDI	Class II	Active
FRU, Cartridge Body O2	24106	FDA UDI	Class I	Active
Ultra PC % Package E	36400	FDA UDI	Class II	Active
FRU, N2O Murphy Gauge, Guardian II	27143	FDA UDI	Class I	Active
Digital Ultra Package C, SS	56200-SS	FDA UDI	Class II	Active
Elbow Mask With Pop-Off Valve	47075	FDA UDI	Class I	Active
N2O Check Valve Riser, FRU	23174-FRU	FDA UDI	Class I	Active
FRU, O2 Murphy Gauge, Guardian II	25381	FDA UDI	Class I	Active
N2O DISS x DISS Hand-Tight Hose ___	34062-HT____	FDA UDI	Class I	Unknown
CV Scavenging Circuit, Basic Replacement	43009	FDA UDI	Class II	Active
Digital Newport Power Coupler	26523-FRU	FDA UDI	Class II	Active
FRU, Vacuum Control, RFS	28327-FRU	FDA UDI	Class II	Active
Accutron 90° EZ-QC Hose Set, 3'	33968-90-3	FDA UDI	Class I	Active
FRU, White Bagtee	26798-FRU	FDA UDI	Class I	Active
Loaner, Digital Flushmount (27076)	L-DIGFLUSHMNT	FDA UDI	Class II	Active
Flowmeter, Digital FlexMount	26400	FDA UDI	Class II	Unknown
Matrx N2O Q/C Hose________FT.	34087-CUSTOM	FDA UDI	Class I	Unknown
Matrx N2O-O2 Q/C Hose Set 5 Ft.	34368-5	FDA UDI	Class I	Active
FRU Check Valve, 4 Cyl	26568	FDA UDI	Class I	Unknown
FRU, Fitting, O2 Quick Connect	24199	FDA UDI	Class I	Active
Oxygen Connector, MQC x O2 DISS, Universal	33969	FDA UDI	Class I	Active
Sample, PIP Triple Pack	28851	FDA UDI	Class I	Active
Micro In-Line Triple DISS Outlet Kit, NS	34012-3-NS	FDA UDI	Class I	Active
FRU, Vacuum Regulator	26988	FDA UDI	Class II	Active
Digi-Flo Pkg B, Manifold w Wall Alarm	49250	FDA UDI	Class I	Active
Oxygen Outlet, Stand-Alone	27793	FDA UDI	Class II	Active
Surface Q/C Vacuum Outlet	34079	FDA UDI	Class I	Active
FRU, DISS Ball Valve, O2	26935	FDA UDI	Class I	Active
FRU, DISS-Instant Adapter, O2	26896	FDA UDI	Class I	Unknown
FRU, Extension, Oxygen Liter/Flowmeter	27429	FDA UDI	Class I	Unknown
Nitrogen Regulator	48075	FDA UDI	Class I	Active
Med Multi Use Non Scavenger Cir	33012-A	FDA UDI	Class II	Unknown
Surface Q/C O2 Outlet	34077	FDA UDI	Class I	Active
Ultra PC% Flowmeter	31975	FDA UDI	Class II	Active
Chairmount, Adec 511	31005-3	FDA UDI	Class II	Active
FRU, Resuscitator Assy	27159	FDA UDI	Class II	Active
Chairmount, Brumaba Oral Surgery OMS	31016-1	FDA UDI	Class II	Active
Accutron O2 Q/C Hose 3 FT.	34070	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (4)

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
Apr 29, 2012	Z-0018-2013	—	terminated	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Apr 29, 2012	Z-0020-2013	—	terminated	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Apr 29, 2012	Z-0019-2013	—	terminated	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Apr 29, 2012	Z-0017-2013	—	terminated	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.