MaxBlend Lite R229P03-005
by Maxtec, Inc.
MaxBlend Lite R229P03-005 is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K161718 on 27 Oct 2016 and listed in FDA GUDID since 14 Jan 2019 (UDI-DI 00817770021780), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817770021780 | Date14 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161718 | Date27 Oct 2016 | StatusActive |
Official records
- AccessGUDID record 00817770021780
- FDA 510(k) database K161718
Across registries
- FDA 510(k) K161718 decided 27 Oct 2016 Active
- FDA GUDID UDI-DI 00817770021780 listed 14 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K161718
- Listed FDA GUDID 00817770021780
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MaxBlend Lite
- Generic name
- Oxygen/air breathing gas mixer, hospital
- Model / reference
- R229P03-005
- Primary DI / UDI-DI
- 00817770021780
- 510(k) Number
- FDA product code
- BZR
- GMDN term
- Oxygen/air breathing gas mixer, hospital
- Device class
- Class II
- Regulation number
- 868.5330
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Oxygen/air breathing gas mixer, hospital.