Identity
- Trade Name
- Digital Newport Flowmeter System FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
- Model / Reference
- 51000 FDA UDI
Identifiers
- Catalog Number
- 51000 FDA UDI
- Primary DI / UDI-DI
- 00813830023312 FDA UDI
- 510(k) Number
- K052335 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oxygen/air/nitrous oxide breathing gas mixer
Digital Newport Flowmeter System by Accutron — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen/air/nitrous oxide breathing gas mixer.
- Midas Flowmeter Control Module, Portable, 60% Max, O2 Control, WHT, SWE — Parker Hannifin Corp. · Class II
- Midas Flowmeter Control Module, Portable, 60% Max, N2O Control, WHT — Parker Hannifin Corp. · Class II
- MIDAS, REMOTE, 60%-W-N2O SWE — Parker Hannifin Corp. · Class II
- MIDAS, PORT, 70%-W-N2O AUS, EAVS — Parker Hannifin Corp. · Class II
- MXR Flow Meter assembly — Parker Hannifin Corp. · Class II
- MIDAS, REMOTE, 50%-W-N2O — Parker Hannifin Corp. · Class II
- MIDAS, PORTABLE, 70%-W-O2 AUS — Parker Hannifin Corp. · Class II
- MIDAS, REM, 50%-W-N2O, EAVS — Parker Hannifin Corp. · Class II
Cleared under the same submission
K052335 also covers:
- 56800 Chair Conversion Kit — ACCUTRON
- Automatic Manifold, Digi-Flo — ACCUTRON
- Digital 4 Cylinder Stand — ACCUTRON
- Digital Newport Power Coupler — ACCUTRON
- Digital Ultra Flushmount Package G — ACCUTRON
- Digital Ultra Flushmount Package H — ACCUTRON
- Digital Ultra Flushmount Package H CHAIR — ACCUTRON
- Digital Ultra Flushmount Package I — ACCUTRON
- Digital Ultra Flushmount Pkg. G, NS — ACCUTRON
- Digital Ultra Flushmount Pkg. H NS-CHAIR — ACCUTRON
- Digital Ultra Flushmount Pkg. H, NS — ACCUTRON
- Digital Ultra Flushmount Pkg. I, NS — ACCUTRON
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Accutron
Sources (1)
- FDA UDI c18454be-61f4-4fa4-ae9b-7714ea8c34b2 34 fields · synced Jun 8, 2026