Identity
- Trade Name
- BBN FDA UDI
- Generic Name
- Visitor hygiene coverall FDA UDI
- Device Name
- Disposable Medical Isolation Gown FDA UDI
- Model / Reference
- MI FDA UDI
- Description
- Disposable Medical Isolation Gown FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973980780122 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Visitor hygiene coverall FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Visitor hygiene coverall
Bbn by Jiaxing Zhengqun Medical Devices Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Critical Cover — ALPHAPROTECH, INC. · 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
- Jiaxing Zhengqun Medical Devices Co., Ltd
Sources (1)
- FDA UDI 7431e1e9-0c7f-49ee-a418-07190f3b26a2 33 fields · synced May 30, 2026