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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 4 of 13

Device	Model / Reference	Registries	Class	Status
Digi-Flo Pkg. B, w Wall Alarm - NP	49250-NP	FDA UDI	Class I	Active
Manual Resuscitator	38007	FDA UDI	Class II	Active
Refurbished White Apha III	32000-R	FDA UDI	Class II	Unknown
FRU, O2 Gauge	26907	FDA UDI	Class I	Unknown
Manifold With Wall Alarm, A (2+2), NP	38002-NP	FDA UDI	Class I	Active
FRU, Outspout Assy, Universal White	27136	FDA UDI	Class I	Active
O2 DISS x DISS 90° Hose ___	34061-90____	FDA UDI	Class I	Unknown
Ultra DC Package E	46400	FDA UDI	Class II	Active
Matrx N2O-O2 Q/C Hose Set 4 Ft.	34368-4	FDA UDI	Class I	Active
Flowmeter, CM	31970	FDA UDI	Class II	Active
FRU, DISS-Instant Adapter, Mixed Gas	27409	FDA UDI	Class I	Unknown
Newport Flowmeter System	50000	FDA UDI	Class II	Active
FRU, Accuvalve Assembly	26786-FRU	FDA UDI	Class I	Active
Axess Mask, Medium Mint, 24 Pk	53035-16	FDA UDI	Class I	Active
Adapter, Demand Valve, O2	28085-FRU	FDA UDI	Class I	Active
Digital Ultra Oral Surgery Package D	56300-OS	FDA UDI	Class II	Active
Loaner, CM, 2 Post, DISS	L-CM2PDISS	FDA UDI	Class II	Active
Hood, Capnography Pedo, Unscented 12 Pk	43037-9	FDA UDI	Class I	Unknown
Digital Ultra Package B, Sedation Systems	56100-SS	FDA UDI	Class II	Active
Ultra DC Package F	46500	FDA UDI	Class II	Active
Resuscitator Adaptor	37001	FDA UDI	Class II	Active
90° Mixed Gas Connector	26396	FDA UDI	Class I	Active
OxyQuip Vacuum Male Connector	34084	FDA UDI	Class II	Active
O2 Cannula, 10 Clear Adult, 7' Tubing	33030-10	FDA UDI	Class I	Active
Insert Valve Guardian II, FRU	26737-FRU	FDA UDI	Class I	Unknown
Digi-Flo Pkg D, w Sec. Wall Alarm -NP	49450-NP	FDA UDI	Class I	Active
FRU, Display Assy Digi-Flo Zone Valve	28651-FRU	FDA UDI	Class I	Active
Digital Ultra Flushmount Pkg. G, NS	56600-NS	FDA UDI	Class II	Active
Remote Flow System (RFS)	36855	FDA UDI	Class II	Active
Flowmeter, CM DISS	27514	FDA UDI	Class II	Active
2nd Alarm, Digi-Flo, Wall, w Security	49054-S	FDA UDI	Class I	Active
Ultra DC Package B	46100	FDA UDI	Class II	Active
Oxygen Connector, MQC x 1/8 MNPT, Universal	27958	FDA UDI	Class I	Active
Hood, Capnography Adult, Unscented 12 Pk	43035-9	FDA UDI	Class I	Unknown
Matrx Manifold Adapter Kit	27954-FRU	FDA UDI	Class I	Active
FRU, GII Office Controller, Wall Mount	26816-FRU	FDA UDI	Class I	Active
Digital Ultra Oral Surgery Package G	56600-OS	FDA UDI	Class II	Active
Ultra DC Oral Surgery FM/Directional Y Valve	31980-OS	FDA UDI	Class II	Active
Digital Ultra Package C	56200	FDA UDI	Class II	Active
Hose Assy, N2O, 3'	34062	FDA UDI	Class I	Active
Transducer, Guardian II Replacement Kit	25786-FRU	FDA UDI	Class I	Active
Accutron E-Z Q/C Hose Set 10'	33968-10	FDA UDI	Class I	Active
Tank Restraints	34075	FDA UDI	Class I	Unknown
Digi-Flo Pkg. D, w Security Wall Alarm	49450	FDA UDI	Class I	Active
Source Valve Kit	49650	FDA UDI	Class I	Active
Digi-Flo Pkg C, w Sec. Desk Alarm -NP	49350-NP	FDA UDI	Class I	Unknown
FRU, Nitrous Oxide Regulator, Guardian II	34058-GII	FDA UDI	Class I	Active
Hose Set, N2O/O2 PB Male, 3'	34068-3	FDA UDI	Class I	Active
Accutron EZ Vacuum Male Connector	33972	FDA UDI	Class II	Active
Accutron Manifold Adapter Kit	28401-FRU	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

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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.