Identity
- Trade Name
- EMSRUN FDA UDI
- Generic Name
- Burn gel FDA UDI
- Model / Reference
- PZSS0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567743448 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Burn gel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Burn gel
Emsrun by Wuxi Emsrun Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Burn gel.
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- Water-Jel — WATER-JEL TECHNOLOGIES, L.L.C. · U
- Water-Jel — WATER-JEL TECHNOLOGIES, L.L.C. · U
- BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · U
- First Aid Kit 21CT — Shanghai Care US Medical Product Co., Ltd. · Class I
- MEDLINE INDUSTRIES — MEDLINE INDUSTRIES, INC. · U
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
- Wuxi Emsrun Technology Co., Ltd.
Sources (1)
- FDA UDI 6fa2e25d-e8ca-41c6-a242-c806229affde 32 fields · synced Jun 1, 2026