Identity
- Trade Name
- Dr.Protekt Safety First FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Device Name
- Infrared Ear/Forehead Thermometer FDA UDI
- Model / Reference
- PG-IRT1603 FDA UDI
- Description
- Infrared Ear/Forehead Thermometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005478101 FDA UDI
- 510(k) Number
- K182597 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear/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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, ear/skin
Dr.Protekt Safety First by Krisco Sales LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear/skin.
- CHOSEN Infrared Forehead Thermometer — ABOUND Diagnostics, Inc · Class II
- huangirl Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- FIGHTECH — Shenzhen Urion Technology Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Pacom Medical Instruments Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
- MOBI — MOBI TECHNOLOGIES, INC. · Class II
- CONAIR CORPORATION — CONAIR LLC. · Class II
- AlphaMed — Shenzhen Urion Technology Co., Ltd. · Class II
Cleared under the same submission
K182597 also covers:
- Procare Forehead Infrared Thermometer — ARISE MEDICAL LLC
- Santastic Infrared Forehead Thermometer — BUY SUPPLY INC
- Vermax — Coastalaware Holdings Inc
- MuellerMedical Infrared Ear/Forehead Thermometer IT-800 — DOCTOR BEST PRODUCT
- MuellerMedical Infrared Forehead Thermometer IT-700 — DOCTOR BEST PRODUCT
- HOMEDICS — FKA DISTRIBUTING CO., LLC
- HOMEDICS — HOMEDICS USA, LLC
- JUMAX — JUMAX HEALTHCARE LLC
- bt-degree — Micro Current Technology, Inc.
- SeemtraMed Infrared Ear/Forehead Thermometer — SEEMTRAMED LLC
- paramed — SILEX GLOBAL LLC
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
- Krisco Sales LLC
Sources (1)
- FDA UDI 649b3c85-799c-491c-b1e4-348a7235173e 34 fields · synced May 30, 2026