Identity
- Trade Name
- MaxFlo2 FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- MaxFlo2 Low Flow DISS Fitting FDA UDI
- Model / Reference
- Low Flow DISS FDA UDI
- Description
- MaxFlo2 Low Flow DISS Fitting FDA UDI
Identifiers
- Catalog Number
- R223P01 FDA UDI
- Primary DI / UDI-DI
- 00853061006005 FDA UDI
- FDA Product Code
- BZR FDA UDI
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5330 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 2.4 Pound FDA UDIDepth — 4.7 Inch FDA UDIWidth — 3.9 Inch FDA UDIHeight — 8.2 Inch FDA UDI
MaxFlo2 by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 db6961d9-db38-4b3f-ab89-10a16ebbc6cb 37 fields · synced May 30, 2026