Identity
- Trade Name
- MAXO2 ME FDA UDI
- Generic Name
- Respiratory oxygen monitor, line-powered FDA UDI
- Device Name
- AIr/Oxygen Medical Gas Monitor FDA UDI
- Model / Reference
- R230P01 FDA UDI
- Description
- AIr/Oxygen Medical Gas Monitor FDA UDI
Identifiers
- Catalog Number
- R230P01 FDA UDI
- Primary DI / UDI-DI
- 00853061006951 FDA UDI
- 510(k) Number
- K153659 FDA UDI
- FDA Product Code
- CCL FDA UDI
- GMDN Term
- Respiratory oxygen monitor, line-powered 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
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 monitor, line-powered
Maxo2 Me by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Analyzer — Maxtec, Inc. · Class II
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Cleared under the same submission
K153659 also covers:
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 09bacd53-f024-46f9-a300-51c00a7596bf 36 fields · synced May 30, 2026