Identity
- Trade Name
- Kroger FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- KROGER INFRARED THERMOMETER MULTIFUNCTION FDA UDI
- Model / Reference
- 112-935-000 FDA UDI
- Description
- KROGER INFRARED THERMOMETER MULTIFUNCTION FDA UDI
Identifiers
- Catalog Number
- 112-935-000 FDA UDI
- Primary DI / UDI-DI
- 00041260367069 FDA UDI
- 510(k) Number
- K100488 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
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, skin
Kroger by Kroger Co., The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infrared patient thermometer, skin.
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- 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
K100488 also covers:
- Exchange Select — Aafes
- SIGNATURE CARE — BETTER LIVING BRANDS LLC
- HealthSmart — DMS HOLDINGS, INC.,
- HealthSmart — DMS HOLDINGS, INC.,
- HealthSmart — DMS HOLDINGS, INC.,
- Motorola — Exclusive Group, LLC
- Medline — MEDLINE INDUSTRIES, INC.
- Little Journey — Shenzhen Dongdixin Technology Co., Ltd.
- Philips Avent ear thermometer — Shenzhen Dongdixin Technology Co., Ltd.
- Philips ear thermometer — Shenzhen Dongdixin Technology Co., Ltd.
- UP & UP — TARGET CORPORATION
- UP&UP — TARGET CORPORATION
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
- Kroger Co., The
Sources (1)
- FDA UDI 3f81e0a9-f065-4c4e-99cf-c34b5073dd8a 35 fields · synced Jun 8, 2026