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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 7 of 13

Device	Model / Reference	Registries	Class	Status
Ultra DC Oral Surgery Package A	46000-OS	FDA UDI	Class II	Unknown
N2O-O2 2+1 Manifold	34063-1	FDA UDI	Class I	Active
FRU, Newport N2O Regulator	25747	FDA UDI	Class I	Active
FRU, Scavenger Hub, EU	25536	FDA UDI	Class II	Active
Ultra PC % Package E, PEU	36400-PEU	FDA UDI	Class II	Active
Matrx O2 Q/C Hose________FT.	34074-CUSTOM	FDA UDI	Class I	Unknown
Adapter, Demand Valve, N2O	28086-FRU	FDA UDI	Class I	Active
FRU, Hose, 4 Cyl O2, International	27285-FRU	FDA UDI	Class I	Active
Digital Ultra Package F	56500	FDA UDI	Class II	Active
FRU, Stem, O2 Outlet	23470-FRU	FDA UDI	Class I	Active
Oxygen Flow Selector Valve, Hex Lock	35015	FDA UDI	Class I	Active
Digital Ultra Flushmount Package I	56950	FDA UDI	Class II	Active
Loaner, PC	L-PC	FDA UDI	Class II	Active
2 Cylinder Portable	42000	FDA UDI	Class I	Unknown
Ultra DC Flowmeter	31980	FDA UDI	Class II	Active
Directional Y Valve	47050	FDA UDI	Class I	Active
Manifold With Wall Alarm, System C (2 + 1)	38004	FDA UDI	Class I	Active
Hose Assy, N2O, 6'	22736	FDA UDI	Class I	Active
Flowmeter, Digital Flushmount, Biewer	27076-BWR	FDA UDI	Class II	Active
Oral Surgery O2, Accessory Package	47000	FDA UDI	Class I	Active
Oxygen Fitting, 1/8" Male PT, Male Q/C without Bracket	27958-FRU	FDA UDI	Class I	Active
Digital 4 Cylinder Stand	54000	FDA UDI	Class II	Active
Hose Assy, O2, 4'	25412	FDA UDI	Class I	Active
Belmed Manifold Adapter Kit	28408-FRU	FDA UDI	Class I	Active
FRU, Scavenging Plug	26252	FDA UDI	Class II	Active
White Axess, RFS Circuit	28624-FRU	FDA UDI	Class II	Active
Pre-Installation Kit for A & C, Wall Alarm	38052	FDA UDI	Class I	Active
Recessed Schrader Q/C Outlet Nitrogen	34010-S	FDA UDI	Class I	Active
In-Line O2 Adapter DISS x DISS FQC	35019	FDA UDI	Class I	Active
White Axess In-Line Circuit	28625-FRU	FDA UDI	Class II	Active
FRU, N2O Hose, 2 Cyl.	27173-FRU	FDA UDI	Class I	Active
FRU Out Spout Leaf Replacement Kit, Old	24554	FDA UDI	Class II	Unknown
FRU, N2O Guage	25527	FDA UDI	Class I	Unknown
FRU, Cone Ring Solid White Tubing	26251	FDA UDI	Class I	Unknown
Hose, Assy, Air (Mixed), 10'	27181	FDA UDI	Class I	Unknown
Digi-Flo Pkg B, Manifold W Wall Alarm, Aus	49250-AUS	FDA UDI	Class I	Active
FRU T-Handle	24549	FDA UDI	Class II	Unknown
FRU, Original Downspout Assy, Taupe	28057	FDA UDI	Class II	Unknown
Oxyquip WAGD MQC x 1/2" Hose	33977	FDA UDI	Class I	Active
Manifold, 2 + 2, Desk Alarm, No Regs or Hoses	34065	FDA UDI	Class I	Active
Nitrogen Hose DISS-3Ft	48078	FDA UDI	Class I	Active
Tube, 6' Corrugated Tube	22137	FDA UDI	Class I	Active
Oxygen Liter Flowmeter With Hex Lock MQC And O2 Barb	35014-HL	FDA UDI	Class I	Active
Hose Set, N2O/O2 PB Male, ___________'	34068-CUSTOM	FDA UDI	Class I	Unknown
Mobile Stand, International	32005-INT	FDA UDI	Class I	Unknown
FRU, Regulator, EU O2 4 Cyl.	25525	FDA UDI	Class I	Active
Hood, Large Mint, 24 Pack	33015-16	FDA UDI	Class I	Active
Regulator, Large O2, Refurbished	34057-RFB	FDA UDI	Class I	Unknown
OxyQuip N2O-O2 Q/C Hose _____ft.	34168-CUSTOM	FDA UDI	Class I	Unknown
Matrx N2O Q/C Hose 3 FT.	34087	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.