Identity
- Trade Name
- LinkTemp FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Non-Contact Infrared Thermometer FDA UDI
- Model / Reference
- LMP001 FDA UDI
- Description
- Non-Contact Infrared Thermometer FDA UDI
Identifiers
- Catalog Number
- LMP001 FDA UDI
- Primary DI / UDI-DI
- 00851028001391 FDA UDI
- 510(k) Number
- K130231 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
No
FDA UDI
Category: Intermittent electronic patient thermometer
LinkTemp by Links Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130231 also covers:
- AccuMed — AMCREST INDUSTRIES LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- Elate — AMPLIM, LLC
- Elate — AMPLIM, LLC
- Easy@Home Non-contact Infrared Thermometer — EASY HEALTHCARE CORPORATION
- Easy@Home Non-contact Infrared Thermometer — EASY HEALTHCARE CORPORATION
- Easy@Home Non-contact Infrared Thermometer — EASY HEALTHCARE CORPORATION
- Thermometer — Rashman Corp.
- Thermometer — Rashman Corp.
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
- Links Medical Products, Inc.
Sources (1)
- FDA UDI b5d7a5a3-38f8-44d9-aaaa-53a82b4759aa 37 fields · synced Sep 18, 2026