Identity
- Trade Name
- Kroger FDA UDI
- Generic Name
- Continuous electronic patient thermometer, battery-powered FDA UDI
- Device Name
- KROGERS COMFORTS FOR BABY FIREFLY 20 SEC FLEX THERMOMETER FDA UDI
- Model / Reference
- 112-705-000 FDA UDI
- Description
- KROGERS COMFORTS FOR BABY FIREFLY 20 SEC FLEX THERMOMETER FDA UDI
Identifiers
- Catalog Number
- 112-705-000 FDA UDI
- Primary DI / UDI-DI
- 00041260345173 FDA UDI
- 510(k) Number
- K041516 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Continuous electronic patient thermometer, battery-powered 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
Yes
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: Continuous electronic patient thermometer, battery-powered
Kroger by Kroger Co., The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041516 also covers:
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- 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.
- 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
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
- Kroger Co., The
Sources (1)
- FDA UDI 7a48e8c5-ef18-4bb7-8e5a-3f236da1edfc 35 fields · synced May 30, 2026