Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- THERMOMETER, TALKING, EAR/FOREHEAD, HOME FDA UDI
- Model / Reference
- MDSTH1002 FDA UDI
- Description
- THERMOMETER, TALKING, EAR/FOREHEAD, HOME FDA UDI
Identifiers
- Catalog Number
- MDSTH1002 FDA UDI
- Primary DI / UDI-DI
- 00080196406404 FDA UDI
- 510(k) Number
- K100488 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
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
Yes
FDA UDI
Category: Intermittent electronic patient thermometer
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intermittent electronic patient thermometer.
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Cleared under the same submission
K100488 also covers:
- Exchange Select — Aafes
- SIGNATURE CARE — BETTER LIVING BRANDS LLC
- HealthSmart — DMS HOLDINGS, INC.,
- HealthSmart — DMS HOLDINGS, INC.,
- HealthSmart — DMS HOLDINGS, INC.,
- Motorola — Exclusive Group, LLC
- Kroger — KROGER CO., THE
- Little Journey — Shenzhen Dongdixin Technology Co., Ltd.
- Philips Avent ear thermometer — Shenzhen Dongdixin Technology Co., Ltd.
- Philips ear thermometer — Shenzhen Dongdixin Technology Co., Ltd.
- UP & UP — TARGET CORPORATION
- UP&UP — TARGET CORPORATION
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 6bd40e78-4d48-46fc-b2c0-a3092894a5ef 37 fields · synced May 31, 2026