Is this your brand? Sign in to claim ownership.

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 3 of 13

Device	Model / Reference	Registries	Class	Status
Hose, O2 DISS 9'	34061-9	FDA UDI	Class I	Active
O2 Cannula, 10 Clear Pediatric, 7' Tubing	33029-10	FDA UDI	Class I	Active
O2 DISS x DISS Hand-Tight Hose ____	34061-HT____	FDA UDI	Class I	Unknown
Chemtron N2O-O2 Hose Set 4 Ft.	34268-4	FDA UDI	Class I	Active
FRU, O2 Shut Off Valve w Gauge	25889	FDA UDI	Class I	Active
Accutron Demand Valve	38011	FDA UDI	Class I	Active
Digital Ultra Flushmount Package H CHAIR	56800-CHAIR	FDA UDI	Class II	Active
Flowmeter, Digital FlushMount, INT	27076-INT	FDA UDI	Class II	Active
Accutron 90° EZ-QC Hose Set, 4'	33968-90-4	FDA UDI	Class I	Active
Schrader Flush Q/C Hose Set 6 Ft.	34668-6	FDA UDI	Class I	Active
Pressure Relief	22486-FRU	FDA UDI	Class I	Active
Oxygen Flowmeter Mounting Bracket	34018	FDA UDI	Class I	Active
Schrader Flush Q/C Hose Set, Custom	34668-CUSTOM	FDA UDI	Class I	Unknown
Pre-Install Digi-Flo B & D Wall Mount	49052	FDA UDI	Class I	Active
Ultra PC % Oral Surgery Package F	36500-OS	FDA UDI	Class II	Active
Hose Assy, O2 DISS, 4'	22731	FDA UDI	Class I	Active
Manifold Test Kit	34055	FDA UDI	Class I	Active
4 Cylinder Stand, Analog, International	28373-INT	FDA UDI	Class I	Active
FRU, N2O E-Yoke (4 Cylinder)	20097-FRU	FDA UDI	Class I	Active
E-Yoke Regulator O2	35013	FDA UDI	Class I	Active
Chemtron N2O-O2 Hose Set 3 Ft.	34268-3	FDA UDI	Class I	Active
Oxygen Regulator	34057	FDA UDI	Class I	Active
FRU, Valve, RFS Vacuum	27393	FDA UDI	Class II	Active
Ultra PC % Oral Surgery Package E	36400-OS	FDA UDI	Class II	Active
CM Installation Kit, Std	36850	FDA UDI	Class I	Active
Chemetron WAGD MQC x 1/2" Hose	33979	FDA UDI	Class I	Active
FRU, Downspout, Taupe	27761	FDA UDI	Class II	Unknown
Schrader InLine N2O-O2 Q/C Set 4 Ft.	34568-4	FDA UDI	Class I	Active
OxyQuip N2O-O2 Q/C Hose Set 6 Ft.	34168-6	FDA UDI	Class I	Active
Riser, FRU, N2O, Cylinder Room	27754	FDA UDI	Class I	Active
FRU, Axess Vacuum Gauge	26699-FRU	FDA UDI	Class II	Active
FRU, E Yoke Handle	27302-FRU	FDA UDI	Class I	Unknown
Matrx O2 Q/C Hose 3 FT.	34074	FDA UDI	Class I	Active
4 Cyl Portable Loaner	44000-LOANER	FDA UDI	Class I	Unknown
Digital Ultra Oral Surgery Package C ADJT	56200-OS-ADJT	FDA UDI	Class II	Active
Hood, Capnography Large Adult, Mint 12 Pk	43034-16	FDA UDI	Class I	Unknown
Oxygen Connector, MQC x O2 DISS, Hex Lock	27253	FDA UDI	Class I	Active
Puritan WAGD MQC x 1/2" Hose	33976	FDA UDI	Class I	Active
Schrader Inline O2 Q/C x DISS Hose ____	34090-CUSTOM	FDA UDI	Class I	Unknown
Main Module, Digital Flushmount	27192	FDA UDI	Class II	Active
Loaner, CM, 2 Post, Instant	L-CM2PINST	FDA UDI	Class II	Active
Hose, ____________' PB N2O Q/C	34071-CUSTOM	FDA UDI	Class I	Unknown
Digital Newport Flowmeter System	51000	FDA UDI	Class II	Active
Recessed Q/C O2 Outlet	34009	FDA UDI	Class I	Active
Chemtron N2O Hose 3 FT.	34086	FDA UDI	Class I	Active
EZ/QC Hose Set__________FT.	33968-CUSTOM	FDA UDI	Class I	Unknown
Hose Assy, O2, 3'	34061	FDA UDI	Class I	Active
FRU, Oxygen Regulator, Guardian II	34057-GII	FDA UDI	Class I	Active
Hose Set, N2O/O2 PB Male, 6'	34068-6	FDA UDI	Class I	Active
Micro Outlet, Dual, DISS	34013	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.