Identity
- Trade Name
- MABIS FDA UDI
- Generic Name
- Continuous electronic patient thermometer, battery-powered FDA UDI
- Device Name
- 60 SECOND FLEX TIP DIGITAL THERMOMETER W/BEEPER FAHRENHEIT FDA UDI
- Model / Reference
- 15-605-000 FDA UDI
- Description
- 60 SECOND FLEX TIP DIGITAL THERMOMETER W/BEEPER FAHRENHEIT FDA UDI
Identifiers
- Catalog Number
- 15-605-000 FDA UDI
- Primary DI / UDI-DI
- 00767056156050 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
- Not 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
Mabis by Dms Holdings, Inc., — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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.
- 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
- Dms Holdings, Inc.,
Sources (1)
- FDA UDI 3939f667-7402-4025-a597-c59d7712a549 36 fields · synced Jun 1, 2026