Identity
- Trade Name
- Exergen Thermographic Scanner FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- DT-5000S-USB FDA UDI
- Model / Reference
- DT-5000S-USB FDA UDI
- Description
- DT-5000S-USB FDA UDI
Identifiers
- Catalog Number
- 124185 FDA UDI
- Primary DI / UDI-DI
- 10834098000966 FDA UDI
- 510(k) Number
- K011291 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, skin 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skin
Exergen Thermographic Scanner by Exergen Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, skin.
- TytoHome — TYTO CARE LTD · Class II
- ALPHAMED — Shenzhen Urion Technology Co., Ltd. · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Famidoc — FAMIDOC USA, INC. · Class II
- Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- Famidoc — Famidoc Technology Company Limited · Class II
- DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II
Cleared under the same submission
K011291 also covers:
- Disposable Caps — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen Corporation
- Exergen Temporal Scanner — Exergen 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
- Exergen Corporation
Sources (1)
- FDA UDI 5a69ec91-6f81-4bec-8098-c4b82312e057 37 fields · synced Jun 9, 2026