Identity
- Trade Name
- MAXFLO2 FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- High Flow System FDA UDI
- Model / Reference
- R223P02-006 FDA UDI
- Description
- High Flow System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817770020790 FDA UDI
- 510(k) Number
- K113232 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Maxflo2 by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K113232 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 749c0c4c-dc66-4a48-968c-7d7a6c9659b5 35 fields · synced May 30, 2026