Identity
- Trade Name
- Procare Forehead Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Model / Reference
- 240540 FDA UDI
Identifiers
- Catalog Number
- PG-IRT1602 FDA UDI
- Primary DI / UDI-DI
- 00372217003021 FDA UDI
- 510(k) Number
- K182597 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, skin
Procare Forehead Infrared Thermometer by Arise Medical Llc — 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
K182597 also covers:
- 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
- Dr.Protekt Safety First — Krisco Sales 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
- Arise Medical Llc
Sources (1)
- FDA UDI 2ee8ab26-bc02-4262-8e09-644a330714c9 34 fields · synced Jun 8, 2026