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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 6 of 13

Device	Model / Reference	Registries	Class	Status
FRU, Domestic O2 Gauge, 2-4 Cylinder	25095-FRU	FDA UDI	Class I	Active
4 Cylinder Stand, Digital, SS	28374-SS	FDA UDI	Class I	Active
Matrx Adaptor (OHMEDA)	35325	FDA UDI	Class II	Active
Schrader Flush O2 Q/C x DISS Hose ____	34093-CUSTOM	FDA UDI	Class I	Unknown
Ultra DC Oral Surgery Package B	46100OS	FDA UDI	Class II	Active
Main Module, Digital Flushmount, Brewer	27192-BWR	FDA UDI	Class II	Active
Digital Ultra™ Flushmount Package G, APAC	56600-APAC	FDA UDI	Class II	Active
Manifold With Desk Alarm, B (2+2), NP	38003-NP	FDA UDI	Class I	Active
Vacuum DISS Hand - Tight x 1/2 Hose	33974	FDA UDI	Class I	Active
Digital Ultra Flushmount Pkg. H NS-CHAIR	56800-CHAIR-NS	FDA UDI	Class II	Active
International Newport Flowmeter System	50000-INT	FDA UDI	Class II	Active
Oxygen Fitting, DISS x Male Q/C with Bracket	27253-FRU	FDA UDI	Class I	Active
FRU, Outspout Assy, Universal Taupe	27135	FDA UDI	Class I	Active
Digital Ultra™ Flowmeter Package B, APAC	56100-APAC	FDA UDI	Class II	Active
Matrx N2O-O2 Q/C Hose Set 6 Ft.	34368-6	FDA UDI	Class I	Active
FRU, Gauge Newport O2	23589-FRU	FDA UDI	Class II	Active
FRU, Gauge, N2O Field Test	25950	FDA UDI	Class I	Unknown
Recessed Q/C Triple Outlet	34004	FDA UDI	Class I	Active
Gas ID Label Strips	23126	FDA UDI	Class I	Unknown
Universal Female Adapter	23854-FRU	FDA UDI	Class I	Active
ClearView Nasal Mask and Capnography Bundle – Pediatric Groovy Grape (pkg. 12)	33037-17-CAP	FDA UDI	Class I	Active
Accutron E-Z Q/C Hose Set 4'	33968-4	FDA UDI	Class I	Active
Digi-Flo Pkg A, Manifold Desk Alarm	49150	FDA UDI	Class I	Unknown
Porter Manifold Adapter Kit	28406-FRU	FDA UDI	Class I	Active
Ultra DC Oral Surgery Package C ADJT	46200-OS-ADJT	FDA UDI	Class II	Active
FRU, Hose, 4 Cyl Domestic O2	27175-FRU	FDA UDI	Class I	Active
Surface Imperial N2 Outlet	34078-I	FDA UDI	Class I	Active
Adaptor, ClearView To Matrx	35360	FDA UDI	Class II	Active
Matrx N2O-O2 Q/C Hose Set 3 Ft.	34368-3	FDA UDI	Class I	Active
Ultra PC % Package D	36300	FDA UDI	Class II	Active
Hose Assy, N2O DISS, 5'	22734	FDA UDI	Class I	Active
N2O-O2 2+2 Manifold	34063	FDA UDI	Class I	Active
Control Module, Digital Flushmount	27112-FRU	FDA UDI	Class II	Active
FRU, Pressure Transducer, 0-100 PSI, NPT	27872-FRU	FDA UDI	Class I	Active
Hood, Capnography Large Adult, Unscented 12 Pk	43034-9	FDA UDI	Class I	Unknown
N2O DISS x DISS 90 DEG HOSE 6'	34062-90-6	FDA UDI	Class I	Active
Universal Cabinet Slide, Analog Bagtee	32008	FDA UDI	Class II	Unknown
Pressure Regulator With Adjustable Liter Flow	35012	FDA UDI	Class I	Active
90 Deg N2O Connector	26393	FDA UDI	Class I	Active
Chemtron N2O Hose_______FT.	34086-CUSTOM	FDA UDI	Class I	Unknown
FRU, CAT 5 Fire Rated Cable Plenum, Controller	27278	FDA UDI	Class I	Active
OxyQuip O2 Q/C Hose 3 FT.	34072	FDA UDI	Class I	Active
Flowmeter, Digital Flexmount, 4 Cyl., SS	26400-4CSS	FDA UDI	Class II	Active
Manifold With Wall Alarm, System A (2 + 2)	38002	FDA UDI	Class I	Active
FRU, Bagtee, Original Style	27154	FDA UDI	Class I	Active
Ultra PC % Package C ADJS	36200-ADJS	FDA UDI	Class II	Active
Ultra PC % Package B	36100	FDA UDI	Class II	Active
FRU, O2 E-Yoke (4 Cylinder)	20096-FRU	FDA UDI	Class I	Active
Chairmount, MTI Oral Surgery 721	31017-1	FDA UDI	Class II	Active
Chemtron N2O-O2 Hose Set_____ Ft.	34268-CUSTOM	FDA UDI	Class I	Unknown

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.