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 2 of 13

Device	Model / Reference	Registries	Class	Status
Manifold, 2 + 2, Wall Alarm, No Regs Or Hoses	34064	FDA UDI	Class I	Active
Hood, Capnography Pedo, Bubblegum 12 Pk	43037-12	FDA UDI	Class I	Unknown
Accutron E-Z Q/C Hose Set 3', Australian	33968-3AUS	FDA UDI	Class I	Active
FRU, Original Downspout Assy, White	24317	FDA UDI	Class I	Unknown
Digital Ultra Package C, International	56200-INT	FDA UDI	Class II	Active
OxyQuip N2O-O2 Q/C Hose Set 5 FT.	34168-5	FDA UDI	Class I	Active
FRU, Regulator, N2O 4 Cyl.	25524	FDA UDI	Class I	Active
O2 DISS x DISS 90 DEG HOSE 8'	34061-90-8	FDA UDI	Class I	Active
Ultra PC % Package A	36000	FDA UDI	Class II	Unknown
Surgical Suction Kit	34014	FDA UDI	Class II	Active
O2 Check Valve Riser, FRU	23173-FRU	FDA UDI	Class I	Active
Loaner, CM, 4 Hole, Instant	L-CM4INST	FDA UDI	Class II	Active
FRU, 3/8 Clear PVC Tubing 6 Ft.	26986	FDA UDI	Class I	Active
Schrader Flush N2O Q/C x DISS Hose ____	34094-CUSTOM	FDA UDI	Class I	Unknown
Adaptor, 90 Deg. Bagtee	26255	FDA UDI	Class I	Active
Chairmount, Boyd Oral Surgery S2600	31014-1	FDA UDI	Class II	Active
Ultra DC Oral Surgery Package B	46100-OS	FDA UDI	Class II	Active
Full Facemask, Child O2	38009	FDA UDI	Class I	Active
Zone Valve Adapter Box, Digi-Flo, NC	49400-NC	FDA UDI	Class I	Active
Add-On Oxygen Cylinder Kit	28191-FRU	FDA UDI	Class I	Active
Axess 90 Deg Outspout Connector	28417-FRU	FDA UDI	Class II	Active
Ohmeda WAGD MQC x 1/2" Hose	33978	FDA UDI	Class I	Active
Loaner, 4 Cylinder Digital Stand	L-4CYLDIGSTND	FDA UDI	Class I	Active
Cannula Adapter, O2	33028	FDA UDI	Class I	Unknown
Chair Conversion Kit	36800-CCK	FDA UDI	Class II	Active
Kit, CM Installation, Std. NS	36850-NS	FDA UDI	Class I	Active
Ultra DC Package C ADJS	46200-ADJS	FDA UDI	Class II	Active
FRU, Domestic O2 Regulator, 2-4 Cyl	26432-FRU	FDA UDI	Class I	Active
Loaner, DC	L-DC	FDA UDI	Class II	Active
Oxygen Liter Flowmeter With Universal MQC And O2 Barb	35014-U	FDA UDI	Class I	Active
Digital Ultra Package D	56300	FDA UDI	Class II	Active
Ultra DC Package U	46500-US	FDA UDI	Class II	Active
N2O DISS x DISS 90 DEG HOSE 10'	34062-90-10	FDA UDI	Class I	Active
Ultra PC% Cabinet Mount Package G, No Shut-Offs	36600-NS	FDA UDI	Class II	Active
FRU Room-Air Override Replacement Kit	24491	FDA UDI	Class I	Active
FRU, Pressure Transducer, 0-100 PSI	27758-FRU	FDA UDI	Class I	Active
Accutron 90° EZ-QC Hose Set, 10 FT	33968-90-10	FDA UDI	Class I	Active
FRU, PC N2O Lock Plug	27236	FDA UDI	Class II	Active
FRU, Oxygen Outlet, Stand-Alone	27793-FRU	FDA UDI	Class II	Active
N2O DISS x DISS 90 DEG HOSE 5'	34062-90-5	FDA UDI	Class I	Active
FRU, Primary Check Valve N2O	23914	FDA UDI	Class I	Active
Adjustable Mobile Stand - Short	42005	FDA UDI	Class I	Active
Chairmount, Royal OS1	31007-6	FDA UDI	Class II	Unknown
Hose Assy, 6' O2 90°	27501	FDA UDI	Class I	Active
Hose, N2O DISS 9'	34062-9	FDA UDI	Class I	Active
Oxygen Flow Selector Valve, 90° Hex Lock	35017	FDA UDI	Class I	Active
E Cylinder Mobile Cart	38001	FDA UDI	Class I	Active
Recessed Imperial Nitrogen Outlet	34010-I	FDA UDI	Class I	Active
FRU, Purge Fitting Set	27319	FDA UDI	Class I	Active
Cart, E Cylinder	20526	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.