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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 11 of 13

Device	Model / Reference	Registries	Class	Status
Chairmount, Sirona Intego	31020-2	FDA UDI	Class II	Active
Pre-Installation for B & D, Desk Alarm	38051	FDA UDI	Class I	Active
Oxygen Manifold System	49000	FDA UDI	Class I	Active
Digital Ultra Flushmount Pkg. I, NS	56950-NS	FDA UDI	Class II	Active
Ultra PC% Cabinet Mount Pkg. H CHAIR	36800-CHAIR	FDA UDI	Class II	Active
RFS Scavenging Circuit I	33008	FDA UDI	Class II	Active
N2O DISS Hand-Tight x DISS 90° Hose ___	34062-90HT____	FDA UDI	Class I	Unknown
Nitrogen Manifold	48020	FDA UDI	Class I	Active
Oxygen Manifold	49020	FDA UDI	Class I	Active
Digital Ultra Flushmount Package H	56800	FDA UDI	Class II	Active
FRU, Tube Slide Double	26253	FDA UDI	Class I	Active
FRU, O2 Murphy Gauge, Std. Manifold	25879	FDA UDI	Class I	Active
Ultra PC% Flowmeter, Australian	31975-AUS	FDA UDI	Class II	Active
Analgesia Gas Machine, Model Digital Ultra	K052335	FDA 510(k)	Class II	Active
Rfs Vacuum Gauge Scavenging Circuit	K033503	FDA 510(k)	Class II	Active
Guardian Low Pressure Alarm Accessory, Model 34076	K992421	FDA 510(k)	Class II	Active
Universal Low Profile Nasal Hoods(1250, 1275, 1350, 1450, 1475, 1550)	K970046	FDA 510(k)	Class I	Active
Pip Low Profile Scavenging System(260 And 261)/Universal Low Profile Scavenging System(260-U And 261-U)	K965239	FDA 510(k)	Class II	Active
Accutron Inc.	33034-10-CAP	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33037-11-CAP	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33018	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33017-12	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	27076-UK	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	33034-16	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33010PEU	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	21178	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	32007	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	54500	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	26254	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	21179	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33020	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	35100	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	35000	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	27176-FRU	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	26400-MS	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	33037-11	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	31975-EU50	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	56100-INT	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	27122-FRU	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	33010EU	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	56600-BWR	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	33034-14	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33037-9	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	33035-10-CAP	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	31975-EU	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	35350	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	53006	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	43003	EUDAMEDFDA UDI	Class IIa	Active
Accutron Inc.	56100	EUDAMEDFDA UDI	Class IIb	Active
Accutron Inc.	53035-9	EUDAMEDFDA UDI	Class IIa	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.