Identity
- Trade Name
- Infrared Ear Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Model / Reference
- 5612 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784561219 FDA UDI
- 510(k) Number
- K041692 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
Yes
FDA UDI
Category: Infrared patient thermometer, ear
Infrared Ear Thermometer by Dynarex Corp. — 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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- Bytech — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class II
- Easy@Home Infrared Ear Thermometers — EASY HEALTHCARE CORPORATION · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
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
- Dynarex Corp.
Sources (1)
- FDA UDI 2e1711eb-57da-4142-9e5d-de602c1be9b7 33 fields · synced Jun 1, 2026