Identity
- Trade Name
- TempaDOT FDA UDI
- Generic Name
- Colour-indication patient thermometer FDA UDI
- Device Name
- TempaDOT Plus F single use Clinical Thermometer with Rectal Sheath FDA UDI
- Model / Reference
- 5192R FDA UDI
- Description
- TempaDOT Plus F single use Clinical Thermometer with Rectal Sheath FDA UDI
Identifiers
- Catalog Number
- TD Plus F FDA UDI
- Primary DI / UDI-DI
- 00016944301066 FDA UDI
- FDA Product Code
- FQZ FDA UDI
- GMDN Term
- Colour-indication patient thermometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2900 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.0022 Pound FDA UDI
Category: Colour-indication patient thermometer
TempaDOT by Medical Indicators — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Colour-indication patient thermometer.
- ATI, Inc. — AMERICAN THERMAL INSTRUMENTS, LLC · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- WROOTBOL NOTIPATCH — ONE POWER · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Temp-n-Toss — AMERICAN THERMAL INSTRUMENTS, LLC · Class II
- ATI, Inc. — AMERICAN THERMAL INSTRUMENTS, LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dr.Tempzone+ — ONE POWER · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Indicators
Sources (2)
- FDA UDI 3c991d71-b7cf-4319-8545-c803c82273b0 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026