Identity
- Trade Name
- Max-14 Oxygen Sensor FDA UDI
- Generic Name
- Respiratory oxygen sensor FDA UDI
- Device Name
- Ohio Medical 806572 FDA UDI
- Model / Reference
- R116P80-004 FDA UDI
- Description
- Ohio Medical 806572 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817770021056 FDA UDI
- 510(k) Number
- K972992 FDA UDI
- FDA Product Code
- CCL FDA UDI
- GMDN Term
- Respiratory oxygen sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1720 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Max-14 Oxygen Sensor by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K972992 also covers:
- 1000 Anesthesia Replacement Oxygen Cell — Avante
- 2000 Anesthesia Replacement Oxygen Cell — Avante
- MAX-1 — Maxtec, Inc.
- MAX-11 (Spanish) — Maxtec, Inc.
- MAX-11i — Maxtec, Inc.
- MAX-12-204 — Maxtec, Inc.
- MAX-12A — Maxtec, Inc.
- MAX-13 — Maxtec, Inc.
- MAX-13 SENSOR, PRECISION MEDICAL 504877 — Maxtec, Inc.
- MAX-13-250 — Maxtec, Inc.
- MAX-13CS — Maxtec, Inc.
- MAX-13CS — Maxtec, Inc.
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
- Maxtec, Inc.
Sources (1)
- FDA UDI f80f2f9a-b560-4a06-aa54-0136cf6613ab 35 fields · synced May 29, 2026