Identity
- Trade Name
- QUALITY CHOICE FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Quality Choice 30 Second Digital Thermometer FDA UDI
- Model / Reference
- 89-355 FDA UDI
- Description
- Quality Choice 30 Second Digital Thermometer FDA UDI
Identifiers
- Catalog Number
- QC-99220 FDA UDI
- Primary DI / UDI-DI
- 00635515992207 FDA UDI
- 510(k) Number
- K041516 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Intermittent electronic patient thermometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
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
Category: Intermittent electronic patient thermometer
Quality Choice by Chain Drug Marketing Association, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041516 also covers:
- Exchange Select — Aafes
- Better Life Technologies — BETTER LIFE TECHNOLOGIES LLC
- CHOICEMMED — Beijing Choice Electronic Technology Co., Ltd.
- QUALITY CHOICE — CHAIN DRUG MARKETING ASSOCIATION, INC.
- QUALITY CHOICE — CHAIN DRUG MARKETING ASSOCIATION, INC.
- QUALITY CHOICE — CHAIN DRUG MARKETING ASSOCIATION, INC.
- HCS — Concordance Healthcare Solutions LLC
- HCS — Concordance Healthcare Solutions LLC
- HCS — Concordance Healthcare Solutions LLC
- MABIS — DMS HOLDINGS, INC.,
- Rexall — DOLGENCORP, LLC
- Rexall — DOLGENCORP, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chain Drug Marketing Association, Inc.
Sources (1)
- FDA UDI a3707cf0-c38e-42a3-814f-672d23b639fb 36 fields · synced May 30, 2026