Identity
- Trade Name
- THERA Plus FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- "THERA DIGITAL THERMOMETER FLEXIBLE 1 CT " FDA UDI
- Model / Reference
- 11012340MB FDA UDI
- Description
- "THERA DIGITAL THERMOMETER FLEXIBLE 1 CT " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696299923 FDA UDI
- 510(k) Number
- K102718 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent electronic patient thermometer
THERA Plus by Fourstar Group Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102718 also covers:
- Assured — Dollar Tree Mdsg Chesapeake Ci
- THERAPlus — FOURSTAR GROUP INC.
- THERAPlus — FOURSTAR GROUP INC.
- THERAPlus — FOURSTAR GROUP INC.
- Theraplus — FOURSTAR GROUP INC.
- FAMILY WELLNESS — Family Dollar Stores
- FAMILY WELLNESS — Family Dollar Stores
- FAMILY WELLNESS — Family Dollar Stores
- Familycare — Hangzhou Universal Electronic Co., Ltd.
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
- Fourstar Group Inc.
Sources (1)
- FDA UDI 54b9b28a-50d4-4b7f-809b-73f26f1bb021 34 fields · synced May 30, 2026