Identity
- Trade Name
- MaxBlend2 FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- MaxBlend2, High Flow 0-15 LPM DISS 50 PSI FDA UDI
- Model / Reference
- High Flow FDA UDI
- Description
- MaxBlend2, High Flow 0-15 LPM DISS 50 PSI FDA UDI
Identifiers
- Catalog Number
- R229P02-010 FDA UDI
- Primary DI / UDI-DI
- 00817770025856 FDA UDI
- 510(k) Number
- K161718 FDA UDI
- FDA Product Code
- BZR FDA UDICCL FDA UDI
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5330 FDA UDI868.1720 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Oxygen/air breathing gas mixer, hospital
MaxBlend2 by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161718 also covers:
- MAXBLEND2 — Maxtec, Inc.
- MAXBLEND2 — Maxtec, Inc.
- MaxBlend Lite — Maxtec, Inc.
- MaxBlend Lite — Maxtec, Inc.
- MaxBlend Lite, High Flow, 70LPM — Maxtec, Inc.
- MaxBlend Lite, Low Flow, 15LPM — Maxtec, Inc.
- MaxBlend Lite, Low Flow, 30LPM — Maxtec, Inc.
- MaxBlend Lite, Low Flow, 3LPM — Maxtec, Inc.
- MaxBlend2 — Maxtec, Inc.
- MaxBlend2 — Maxtec, Inc.
- MaxBlend2 — Maxtec, Inc.
- MaxBlend2 — Maxtec, Inc.
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 baf3867a-a712-46c9-9f49-924934410127 35 fields · synced Jun 1, 2026