Identity
- Trade Name
- AMPMED FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Model / Reference
- AMPCA1W FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810477023606 FDA UDI
- 510(k) Number
- K191251 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
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
Yes
FDA UDI
Category: Infrared patient thermometer, skin
Ampmed by Amplim, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191251 also covers:
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- CALi-MEDi, CALIBEUR, iMeasure, iCalibeur — Shenzhen Calibeur Industries Co., Ltd.
- CALi-MEDi, CALIBEUR, iMeasure, iCalibeur — Shenzhen Calibeur Industries Co., Ltd.
- Calibeur — Shenzhen Calibeur Industries Co., Ltd.
- Calibeur — Shenzhen Calibeur Industries 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
- Amplim, Llc
Sources (1)
- FDA UDI d42bbe4b-a8f4-4743-bb3f-081cbbb58842 33 fields · synced Jun 1, 2026