Identity
- Trade Name
- Oxygen Sensor FDA UDI
- Generic Name
- Respiratory oxygen sensor FDA UDI
- Model / Reference
- 10-10319 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043103197 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Respiratory oxygen sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Respiratory oxygen sensor
Oxygen Sensor by Mercury Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen sensor.
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Artema Anesthetic Oxygen (O2) Sensor — Philips DS North America LLC · Class II
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH · Class II
- MAX-13 SENSOR, PRECISION MEDICAL 504877 — Maxtec, Inc. · Class II
- Vapotherm — Vapotherm Inc.
- Analytical Industries Inc. — ANALYTICAL INDUSTRIES, INC. · Class II
- 6600-1278-600 — City Technology Limited · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mercury Enterprises, Inc.
Sources (1)
- FDA UDI adc40b4e-d1be-4ac6-a1dc-4c13d8c42019 33 fields · synced Jun 1, 2026