Identity
- Trade Name
- HEB in Control FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- HEB 60S RIGID DIGITAL THERMOMETER FDA UDI
- Model / Reference
- H-DTR60 FDA UDI
- Description
- HEB 60S RIGID DIGITAL THERMOMETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00041220873869 FDA UDI
- 510(k) Number
- K163518 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Intermittent electronic patient thermometer 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: Intermittent electronic patient thermometer
HEB in Control by H. E. Butt Grocery Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent electronic patient thermometer.
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- ESSEF — Hangzhou Hua'An Medical & Health Instruments Co., · Class II
- Rongfeng — Shen Zhen Rong Feng Technology Co., Ltd. · Class II
- iProvèn — Masena Invest B.V. · Class II
- Rite Aid — 180 INNOVATIONS LLC · Class II
- Family Wellness — Family Dollar Stores · Class II
- up&up — TARGET CORPORATION · Class II
Cleared under the same submission
K163518 also covers:
- ACCUFLEXPRO+ ORAL THERMOMETER (BLUE) — A.M.G. Médicale Inc
- ACCUFLEXPRO+ RECTAL THERMOMETER (RED) — A.M.G. Médicale Inc
- PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue) — A.M.G. Médicale Inc
- PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red) — A.M.G. Médicale Inc
- Physio Logic Accuflex Digital Thermometer — A.M.G. Médicale Inc
- Physio Logic Accuflex Digital Thermometer - Red — A.M.G. Médicale Inc
- PhysioLogic DigiPro+ 30 second Digital Oral Thermometer — A.M.G. Médicale Inc
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- HEB in Control — H. E. BUTT GROCERY COMPANY
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
- H. E. Butt Grocery Company
Sources (1)
- FDA UDI 7fa1b233-eb4f-48b3-ac16-82d736b0c6c1 34 fields · synced Jun 8, 2026