Identity
- Trade Name
- Disposable Full Bodysuit & Accessories FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- The body included: hood, jumpsuit & shoe cover Accessories: goggles, gloves & Y0384 mask Water repellency, full cover, front zipper, elastic cuff, disposable FDA UDI
- Model / Reference
- Y0366 FDA UDI
- Description
- The body included: hood, jumpsuit & shoe cover Accessories: goggles, gloves & Y0384 mask Water repellency, full cover, front zipper, elastic cuff, disposable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08936064200037 FDA UDI
- FDA Product Code
- FXO FDA UDI
- GMDN Term
- Isolation gown, single-use 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
Yes
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: Isolation gown, single-use
Disposable Full Bodysuit & Accessories by Tng Investment And Trading Joint Stock Company — Class I — FDA UDI — listed in FDA GUDID
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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
- Tng Investment And Trading Joint Stock Company
Sources (1)
- FDA UDI 088aed04-98de-410c-b7b4-53114531907f 33 fields · synced Jun 8, 2026