Identity
- Trade Name
- Loaner, CM, 2 Post, Instant FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
- Model / Reference
- L-CM2PINST FDA UDI
Identifiers
- Catalog Number
- L-CM2PINST FDA UDI
- Primary DI / UDI-DI
- 00813830023787 FDA UDI
- 510(k) Number
- K970163 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
Loaner, CM, 2 Post, Instant by Accutron — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oxygen/air/nitrous oxide breathing gas mixer.
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- MIDAS, REM, 50%-W-N2O, EAVS — Parker Hannifin Corp. · Class II
Cleared under the same submission
K970163 also covers:
- Chair Conversion Kit — ACCUTRON
- Chairmount, Adec 511 — ACCUTRON
- Chairmount, Boyd Oral Surgery S2600 — ACCUTRON
- Chairmount, MTI Oral Surgery 721 — ACCUTRON
- Chairmount, Sirona Intego — ACCUTRON
- Chairmount, Sirona Teneo — ACCUTRON
- FRU, Oxygen Outlet, Stand-Alone — ACCUTRON
- FRU, Oxygen Selector Valve — ACCUTRON
- Flowmeter, CM Assy — ACCUTRON
- Flowmeter, CM DISS — ACCUTRON
- Kit, PC To Remote Outlet — ACCUTRON
- Loaner, CM, 4 Hole, Instant — 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 07b35efb-c0c8-4109-bb13-40ac178ef99e 34 fields · synced May 30, 2026