Identity
- Trade Name
- Pharmaceutical Innovations FDA UDI
- Generic Name
- Gel warmer FDA UDI
- Device Name
- UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Navy. FDA UDI
- Model / Reference
- UltraWarmer Gel Warmer - Navy FDA UDI
- Description
- UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Navy. FDA UDI
Identifiers
- Catalog Number
- 36-1100-02 FDA UDI
- Primary DI / UDI-DI
- 00300361100020 FDA UDI
- FDA Product Code
- EFC FDA UDI
- GMDN Term
- Gel warmer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6100 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gel warmer
Pharmaceutical Innovations by Pharmaceutical Innovations, Inc. — 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
- Lotion/Gel Warmer — COMPASS HEALTH BRANDS CORP. · Class I
- Lotion/Gel Warmer — COMPASS HEALTH BRANDS CORP. · Class I
- Lotion/Gel Warmer — COMPASS HEALTH BRANDS CORP. · Class I
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
- Pharmaceutical Innovations, Inc.
Sources (1)
- FDA UDI 080a13aa-8b91-41d4-9964-cc7d9ff4504d 35 fields · synced Jun 1, 2026