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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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Mark Dammann
- EUDAMED SRN
- US-MF-000009363
- FDA FEI Number
- 2020813
- DUNS Number
- —
Catalogue (646)
Page 1 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chemtron O2 Q/C Hose________FT. | 34085-CUSTOM | FDA UDI | Class I | Unknown |
| WAGD Chemetron x 1/2" MNPT | 34976 | FDA UDI | Class I | Active |
| Manifold With Wall Alarm, C (2+1), NP | 38004-NP | FDA UDI | Class I | Active |
| Riser, FRU, O2, Cylinder Room | 27752 | FDA UDI | Class I | Active |
| Adapter, FRU, Porter To Digital | 27518 | FDA UDI | Class II | Active |
| FRU, WAGD Vacuum Hose | 27397 | FDA UDI | Class II | Unknown |
| Digi-Flo N2O & O2 Brazed Risers | 28389-FRU | FDA UDI | Class I | Active |
| N2O DISS x DISS 90 DEG HOSE 8' | 34062-90-8 | FDA UDI | Class I | Active |
| Accu-Vac | 56955 | FDA UDI | Class II | Active |
| FRU, N2O Shut Off Valve w Gauge | 25888 | FDA UDI | Class I | Active |
| Chemtron N2O-O2 Hose Set 6 Ft | 34268-6 | FDA UDI | Class I | Active |
| Small Multi Use Non Scavenger Cir | 33013-A | FDA UDI | Class II | Unknown |
| 4 Cylinder Stand, Digital, FRU | 28374-FRU | FDA UDI | Class I | Active |
| FRU Newport O2 Regulator | 25746 | FDA UDI | Class I | Active |
| Flowmeter, Digital Flexmount, 4 Cyl, UK | 26400-4CUK | FDA UDI | Class II | Active |
| PIP Scavenging Circuit, Basic Replacement | 33009 | FDA UDI | Class II | Active |
| FRU, N2O Murphy Gauge, Std. Manifold | 25880 | FDA UDI | Class I | Active |
| Schrader InLine N2O-O2 Q/C Set 3 Ft | 34568-3 | FDA UDI | Class I | Active |
| Hose, N2O DISS ________' | 34062-CUSTOM | FDA UDI | Class I | Unknown |
| Zone Valve, Digi-Flo | 49550 | FDA UDI | Class I | Active |
| OxyQuip O2 Q/C Hose _______Ft. | 34072-CUSTOM | FDA UDI | Class I | Unknown |
| 4 Cylinder Stand, Digital | 28374 | FDA UDI | Class I | Active |
| Ultra DC Oral Surgery Package A | 46000OS | FDA UDI | Class II | Unknown |
| O2 DISS x DISS 90 DEG HOSE 6' | 34061-90-6 | FDA UDI | Class I | Active |
| FRU, Primary Check Valve O2 | 23913 | FDA UDI | Class I | Active |
| Flowmeter, CM Assy | 27025 | FDA UDI | Class II | Active |
| Nitrogen Add On Kit | 48022 | FDA UDI | Class I | Active |
| Accutron Vacuum Male Connector | 34081 | FDA UDI | Class II | Active |
| FRU, Check Valve Vacuum | 24176 | FDA UDI | Class II | Active |
| Ultra DC Oral Surgery Package F | 46500-OS | FDA UDI | Class II | Active |
| Hand-held Resuscitator Ambu type | 38012 | FDA UDI | Class II | Active |
| FRU Ultra Lens Cover | 24551 | FDA UDI | Class II | Unknown |
| FRU, 4 Cylinder Remote Vacuum Kit | 28326-FRU | FDA UDI | Class II | Active |
| Reducer 1/4 NPT To 1/8 NPT | 27082-FRU | FDA UDI | Class I | Active |
| Accutron E-Z Q/C Hose Set 6 FT | 33968-6 | FDA UDI | Class I | Active |
| Hose, 3' PB N2O Q/C | 34071 | FDA UDI | Class I | Active |
| FRU, Axess To Accuvac Adaptor | 28559-FRU | FDA UDI | Class II | Active |
| N2 DISS Hand-Tight 90° x 1/2" Schrader FQC | 35005 | FDA UDI | Class I | Active |
| FRU, DISS-Instant Adapter, N2O | 26895 | FDA UDI | Class I | Active |
| Surgical Suction Kit, PB | 34014-PB | FDA UDI | Class I | Active |
| FRU, Remote Bagtee Chair Mount | 25042 | FDA UDI | Class II | Unknown |
| Main Module, Digital FlushMount | 27192-FRU | FDA UDI | Class II | Active |
| Digital Ultra Oral Surgery Package E | 56400-OS | FDA UDI | Class II | Active |
| Surface Q/C Triple Outlet | 34060 | FDA UDI | Class I | Active |
| Chemtron Vacuum Male Connector | 34088 | FDA UDI | Class II | Active |
| FRU Mounting Adaptor | 24552 | FDA UDI | Class II | Unknown |
| Hose Assy, N2O DISS, 4' | 22732 | FDA UDI | Class I | Active |
| FRU Newport tank Restraint Strap Replacement Kit | 25681 | FDA UDI | Class I | Unknown |
| Ultra PC % Package F | 36500 | FDA UDI | Class II | Active |
| 56800 Chair Conversion Kit | 56800-CCK | FDA UDI | Class II | Active |
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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. |