Identity
- Trade Name
- Lotion/Gel Warmer FDA UDI
- Generic Name
- Gel warmer FDA UDI
- Device Name
- Gray 3 Bottle Warmer (120V) FDA UDI
- Model / Reference
- 201-788 FDA UDI
- Description
- Gray 3 Bottle Warmer (120V) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853904006087 FDA UDI
- FDA Product Code
- IRQ FDA UDI
- GMDN Term
- Gel warmer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5950 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gel warmer
Lotion/Gel Warmer by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gel warmer.
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- Gel warmer — Shenzhen Wisonic Medical Technology Co., Ltd. · Class II
- Pharmaceutical Innovations — Pharmaceutical Innovations, Inc. · Class I
- Heater for Coupling Gel — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Heater for Coupling Gel(inc cable) — Shenzhen Mindray Bio-Medical Electronics Co. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI d8a9c8f8-5bbe-4b75-b6e6-f88f9a02d3d2 34 fields · synced May 30, 2026