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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 8 of 13

Device	Model / Reference	Registries	Class	Status
Ultra PC Oral Surgery FM/Directional Y Valve	31975-OS	FDA UDI	Class II	Active
Ultra PC % Package U	36500-US	FDA UDI	Class II	Active
Schrader Flush Q/C Hose Set 3 Ft.	34668-3	FDA UDI	Class I	Active
Yoke, 4 Cyl. Tank, FRU	26607-FRU	FDA UDI	Class I	Active
Ultra DC Package A	46000	FDA UDI	Class II	Unknown
Micro In-Line Dual DISS Outlet Kit, NS	34013-3-NS	FDA UDI	Class I	Active
Ultra PC% Cabinet Mount Package H	36800	FDA UDI	Class II	Active
W.A.G.D. DISS Hand-Tight x 1/2" Hose	33975	FDA UDI	Class I	Active
ClearView Nasal Mask and Capnography Bundle – Pediatric Unscented Grey (pkg. 12)	33037-9-CAP	FDA UDI	Class I	Active
Digital Ultra Package E	56400	FDA UDI	Class II	Active
Floor Q/C Dual Outlet	34003	FDA UDI	Class I	Active
Accutron E-Z Q/C Hose Set 5 FT	33968-5	FDA UDI	Class I	Active
Hose Assy, O2 DISS, 5'	22733	FDA UDI	Class I	Active
Loaner, Digital Newport	L-DNP	FDA UDI	Class II	Active
Hose Assy, O2, 10'	27182	FDA UDI	Class I	Active
Accutron Portable Oxygen System	38010	FDA UDI	Class I	Active
FRU, Oxygen Selector Valve	27772	FDA UDI	Class II	Active
RFS for Digital Ultra	56855	FDA UDI	Class II	Active
Ultra PC % Cabinet Mount Package G	36600	FDA UDI	Class II	Active
Vacuum Regulator Mounting Bracket	34017	FDA UDI	Class I	Active
Ultra PC % Package F, PEU	36500-PEU	FDA UDI	Class II	Active
Oxygen Fitting, DISS with Female Q/C	26849-FRU	FDA UDI	Class I	Active
Schrader InLine N2O-O2 Q/C Set 5 Ft.	34568-5	FDA UDI	Class I	Active
Ultra DC Oral Surgery Package D	46300-OS	FDA UDI	Class II	Active
Ultra PC % Package C	36200	FDA UDI	Class II	Active
Schrader InLine N2O-O2 Q/C Set 6 Ft.	34568-6	FDA UDI	Class I	Active
4 Cylinder Stand, Analog	28373	FDA UDI	Class I	Active
FRU, Valve, Pressure Relief, Digi-Flo	27427-FRU	FDA UDI	Class I	Active
Schrader Flush Q/C Hose Set 5 Ft.	34668-5	FDA UDI	Class I	Active
Hose Set, N2O/O2 PB Male, 5'	34068-5	FDA UDI	Class I	Active
2 Cyl. Portable Loaner	42000-LOANER	FDA UDI	Class I	Active
FRU, Regulator, O2 4 Cyl.	27015	FDA UDI	Class I	Active
Digi-Flo Pkg. A, w Desk Alarm - NP	49150-NP	FDA UDI	Class I	Unknown
N2O DISS x DISS 90° Hose ___	34062-90____	FDA UDI	Class I	Unknown
Matrx N2O-O2 Q/C Hose Set______ft	34368-CUSTOM	FDA UDI	Class I	Unknown
Loaner, Digital Portable (Before 2010)	L-DIGPORTOLD	FDA UDI	Class II	Active
Zone Valve Adapter Box, Digi-Flo	49400	FDA UDI	Class I	Active
Ultra PC % Oral Surgery Package A	36000OS	FDA UDI	Class II	Unknown
Oxygen Flow Selector Valve, Universal	35016	FDA UDI	Class I	Active
Mobile Stand	32005	FDA UDI	Class I	Active
Chemtron N2O-O2 Hose Set 5 Ft.	34268-5	FDA UDI	Class I	Active
4 Cylinder Stand, Digital, International	28374-INT	FDA UDI	Class I	Active
Pre-Installation For B & D	39052	FDA UDI	Class I	Unknown
Digital Ultra Flushmount Pkg. H, NS	56800-NS	FDA UDI	Class II	Active
FRU, 4 Cyl Check Valve	27168-FRU	FDA UDI	Class I	Active
Oxygen DISS with O2 Barb Fitting	24589-FRU	FDA UDI	Class I	Active
Nitrogen Manifold System 2 Tank	48000	FDA UDI	Class I	Active
FRU, O2 Hose, 2 Cyl.	27172-FRU	FDA UDI	Class I	Active
Oxygen Connector, MQC x O2 DISS, Universal	27254	FDA UDI	Class I	Active
FRU, Vacuum Connector With Barbs	27324	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

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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.