Identity
- Trade Name
- Oxygen Sensor FDA UDI
- Generic Name
- Respiratory oxygen sensor FDA UDI
- Device Name
- Oxygen Sensor OOMLF204 FDA UDI
- Model / Reference
- OOMLF204 FDA UDI
- Description
- Oxygen Sensor OOMLF204 FDA UDI
Identifiers
- Catalog Number
- E1002573 FDA UDI
- Primary DI / UDI-DI
- 04036616010900 FDA UDI
- 510(k) Number
- K082655 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
- 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
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Height — 42 Millimeter FDA UDIOuter Diameter — 30 Millimeter FDA UDI
Category: Respiratory oxygen sensor
Oxygen Sensor by Honeywell Healthcare Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Honeywell Healthcare Solutions GmbH
Sources (1)
- FDA UDI 179b8040-26f9-4aa0-9721-0bf8da8d45c9 38 fields · synced May 30, 2026