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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 9 of 13

Device	Model / Reference	Registries	Class	Status
Scavenging Control, Outlet Mount	33973	FDA UDI	Class II	Active
22" 5 Leg Stand Base	28350-FRU	FDA UDI	Class I	Active
Full Facemask, Adult O2	38008	FDA UDI	Class I	Active
Digital Ultra Pkg, B, Sed. System, w Bag	56100-SSB	FDA UDI	Class II	Unknown
Accutron E-Z Q/C Hose Set 3'	33968-3	FDA UDI	Class I	Active
FRU, Downspout, White	27760	FDA UDI	Class II	Unknown
2nd Alarm Panel, Digi-Flo, Wall	49054	FDA UDI	Class I	Active
Porter Mobile Stand Adapter	32010	FDA UDI	Class I	Active
Digital Ultra Pkg, B, Sed. System, w Bag	56100-SSB	FDA UDI	Class II	Active
Hose, White 25'	28146	FDA UDI	Class I	Active
FRU, Axess Scavenging Control, In-Line	28530-FRU	FDA UDI	Class II	Active
O2 DISS x DISS 90 DEG HOSE 5'	34061-90-5	FDA UDI	Class I	Active
Ultra PC % Oral Surgery Package C ADJT	36200-OS-ADJT	FDA UDI	Class II	Active
Loaner, Digital Main Module	L-DIGMAIN	FDA UDI	Class II	Active
Scav Circuit - BelMed	20178	FDA UDI	Class II	Active
FRU, DISS Ball Valve, N2O	26934	FDA UDI	Class I	Active
Schrader Inline N2O Q/C x DISS Hose ____	34091-CUSTOM	FDA UDI	Class I	Unknown
FRU, Vacuum Connector for Vacuum Regulator	26901	FDA UDI	Class II	Active
Accutron 90° EZ-QC Hose Set, 5'	33968-90-5	FDA UDI	Class I	Active
E Yoke Regulator Deluxe	35018	FDA UDI	Class I	Active
Micro In-Line Dual DISS Outlet Kit	34013-3	FDA UDI	Class I	Active
Loaner, Digital Portable (2010 & Later)	L-DIGPORTNEW	FDA UDI	Class II	Active
Kit, PC To Remote Outlet	27542	FDA UDI	Class II	Active
Ultra PC % Oral Surgery Package D	36300-OS	FDA UDI	Class II	Active
Hood, Capnography Adult, Vanilla 12 Pk	43035-14	FDA UDI	Class I	Unknown
Digital Ultra Oral Surgery Package H	56800-OS	FDA UDI	Class II	Active
FRU, Hose, Mixed Gas, Original	24344-FRU	FDA UDI	Class I	Unknown
Ultra DC Oral Surgery Package C	46200OS	FDA UDI	Class II	Active
FRU, Vacuum Tubing 6'	27132	FDA UDI	Class II	Active
Ultra DC Package C	46200	FDA UDI	Class II	Active
OxyQuip N2O Q/C Hose 3 FT.	34073	FDA UDI	Class I	Active
Digi-Flo Pkg C, w Sec. Desk Alarm	49350	FDA UDI	Class I	Unknown
Manifold With Desk Alarm, System B (2 + 2)	38003	FDA UDI	Class I	Active
O2 DISS x DISS 90 DEG HOSE 3'	34061-90-3	FDA UDI	Class I	Active
Large Multi Use Non Scavenger Cir	33011-A	FDA UDI	Class II	Unknown
Manifold With Desk Alarm, System D (2 + 1)	38005	FDA UDI	Class I	Active
Reducers Side Tube (pkg of 2)	20305	FDA UDI	Class I	Active
Pre-Install Digi-Flo A & C Desk Mount	49051	FDA UDI	Class I	Unknown
FRU, Original Outspout Assy, White	25812	FDA UDI	Class I	Unknown
Manifold With Desk Alarm, D (2+1), NP	38005-NP	FDA UDI	Class I	Active
Flowmeter, Flexmount, International	26400-INT	FDA UDI	Class II	Unknown
4 Cylinder Portable (w/out Flowmeter)	44000	FDA UDI	Class I	Active
Automatic Manifold, Digi-Flo	27497-FRU	FDA UDI	Class II	Active
Recessed Q/C Dual Outlet	34005	FDA UDI	Class I	Active
Ultra PC % Package F, EU	36500-EU	FDA UDI	Class II	Active
Hose Set, N2O/O2 PB Male, 4'	34068-4	FDA UDI	Class I	Active
Portable O2 System - Manual Resuscitator	38006	FDA UDI	Class II	Active
FRU, New OutSpout Leaf	27424	FDA UDI	Class I	Unknown
Ultra PC% Oral Surgery Package H	36800-OS	FDA UDI	Class II	Active
Ultra PC % Oral Surgery Package C	36200-OS	FDA UDI	Class II	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.