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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 5 of 13

Device	Model / Reference	Registries	Class	Status
FRU, Cartridge Body N2O	24107	FDA UDI	Class I	Active
O2 DISS x DISS 90 DEG HOSE 10'	34061-90-10	FDA UDI	Class I	Active
Ultra PC% Oral Surgery Package A	36000-OS	FDA UDI	Class II	Unknown
OxyQuip N2O Q/C Hose______Ft.	34073-CUSTOM	FDA UDI	Class I	Unknown
Digital Ultra Oral Surgery Package C	56200-OS	FDA UDI	Class II	Active
Ultra PC % Oral Surgery Package B	36100-OS	FDA UDI	Class II	Active
Hose, N2O DISS 8'	34062-8	FDA UDI	Class I	Active
Oxygen Fitting, 1/8" Male PT, Male Q/C with Bracket	27775-FRU	FDA UDI	Class I	Active
Matrx Vacuum Male Connector	34080	FDA UDI	Class II	Active
Digital Ultra Oral Surgery Package B	56100-OS	FDA UDI	Class II	Active
FRU, Hose Assy, Black Mixed Gas DISS, 2'	27671-FRU	FDA UDI	Class I	Active
Micro In-Line Triple DISS Outlet Kit	34012-3	FDA UDI	Class I	Active
Digital Ultra Oral Surgery Package F	56500-OS	FDA UDI	Class II	Active
CM Installation Kit, RFS	36825	FDA UDI	Class II	Active
Non-Scavenging Circuit	33010-A	FDA UDI	Class II	Unknown
Surface Schrader N2 Outlet	34078-S	FDA UDI	Class I	Active
Accutron 90° EZ-QC Hose Set, _______'	33968-90-CUSTOM	FDA UDI	Class I	Unknown
Ultra PC% Cabinet Mount Oral Surgery Package G	36600-OS	FDA UDI	Class II	Active
Digital Ultra Package C ADJS	56200-ADJS	FDA UDI	Class II	Active
Regulator, Large N2O, Refurbished	34058-RFB	FDA UDI	Class I	Unknown
4 Cylinder Stand, Analog	28500	FDA UDI	Class I	Unknown
Zone Valve, Standard Manifold	39550	FDA UDI	Class I	Active
Oxygen Fitting, DISS x Male Q/C without Bracket	27254-FRU	FDA UDI	Class I	Active
Ultra DC Oral Surgery Package E	46400-OS	FDA UDI	Class II	Active
Nitrous Oxide Regulator	34058	FDA UDI	Class I	Active
OxyQuip N2O-O2 Q/C Hose Set 3 FT.	34168-3	FDA UDI	Class I	Active
N2O DISS x DISS 90 DEG HOSE 3'	34062-90-3	FDA UDI	Class I	Active
Loaner, CM, Original, DISS	L-CMORIGDISS	FDA UDI	Class II	Active
Pre-installation for A & C, Desk Mount	39051	FDA UDI	Class I	Unknown
Hose, O2 DISS 8'	34061-8	FDA UDI	Class I	Active
Chairmount, Sirona Teneo	31020-1	FDA UDI	Class II	Active
Hose, O2 DISS __________'	34061-CUSTOM	FDA UDI	Class I	Unknown
FRU, N2O Lock Key Set	24555	FDA UDI	Class II	Unknown
O2 DISS Hand-Tight x DISS 90° Hose ___	34061-90HT____	FDA UDI	Class I	Unknown
Ultra DC Package D	46300	FDA UDI	Class II	Active
Canisters, 5 Disposable	34016	FDA UDI	Class II	Active
Ultra PC% Cabinet Mount Pkg. H NS-CHAIR	36800-CHAIR-NS	FDA UDI	Class II	Active
FRU, Secondary Check Valve Assy	24102	FDA UDI	Class II	Active
Flowmeter, CM assembly	27150	FDA UDI	Class II	Unknown
Accutron 90° EZ-QC Hose Set, 6'	33968-90-6	FDA UDI	Class I	Active
Kit, Accessories, CM/RFS	26227	FDA UDI	Class II	Active
Hose Assy, N2O, 4'	27243	FDA UDI	Class I	Active
Chemtron O2 Hose 3 FT.	34085	FDA UDI	Class I	Active
OxyQuip N2O-O2 Q/C Hose Set 4 FT.	34168-4	FDA UDI	Class I	Active
Adjustable Talll Mobile Stand	32005-AT	FDA UDI	Class I	Active
Loaner, Digital Control Module	L-DIGCONTROL	FDA UDI	Class II	Active
Alpha III flowmeter - Medical Gas	32000-MG	FDA UDI	Class II	Unknown
FRU, InLine Vacuum Controller	22122	FDA UDI	Class II	Active
Digital Ultra Flushmount Package G	56600	FDA UDI	Class II	Active
Deluxe Portable Oxygen System	38013	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.