Identity
- Trade Name
- ProCare IR Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- ProCare IR Thermometer - EFT 161 FDA UDI
- Model / Reference
- 240390 FDA UDI
- Description
- ProCare IR Thermometer - EFT 161 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372217003014 FDA UDI
- 510(k) Number
- K171214 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, skinInfrared patient thermometer, ear
ProCare IR 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, ear.
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Cleared under the same submission
K171214 also covers:
- Bjingles — NK AMERICAN WAY, LLC
- Bjingles — NK AMERICAN WAY, LLC
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- North American Health Wellness — Shenzhen Brav Electronic Technologies Co., Ltd.
- SMARTRO — Shenzhen Brav Electronic Technologies 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
- Arise Medical Llc
Sources (1)
- FDA UDI 663fe8bd-2943-4331-a290-85361804b80b 34 fields · synced Jun 8, 2026