Quality Choice 89-355
by Chain Drug Marketing Association, Inc.
Quality Choice 89-355 (QC-99220) is a Class II device made by Chain Drug Marketing Association, Inc., cleared under FDA 510(k) K041516 on 8 Sep 2004 and listed in FDA GUDID since 15 Feb 2017 (UDI-DI 00635515992207), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00635515992207 | Date15 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041516 | Date8 Sep 2004 | StatusActive |
Official records
- AccessGUDID record 00635515992207
- FDA 510(k) database K041516
Across registries
- FDA 510(k) K041516 decided 8 Sep 2004 Active
- FDA GUDID UDI-DI 00635515992207 listed 15 Feb 2017 Listed
Recalls
-
- Terminated Z-0506-2012
The thermometers have been reported to have inaccurate readings
Timeline
- Cleared FDA 510(k) K041516
- Recall initiated FDA recalls Z-0506-2012
- Listed FDA GUDID 00635515992207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Quality Choice
- Generic name
- Intermittent electronic patient thermometer
- Model / Ref / Catalog
- 89-355, QC-99220
- Primary DI / UDI-DI
- 00635515992207
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Intermittent electronic patient thermometer
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Intermittent electronic patient thermometer.
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