Identity
- Trade Name
- NYES Protect4 FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Disposable Isolation Gown, AAMI Level 2, XLarge by Coulmed FDA UDI
- Model / Reference
- NYES400-2 FDA UDI
- Description
- Disposable Isolation Gown, AAMI Level 2, XLarge by Coulmed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008955135 FDA UDI
- FDA Product Code
- OEA 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
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: Isolation gown, single-use
NYES Protect4 by New York Embroidery Studio — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- New York Embroidery Studio
Sources (1)
- FDA UDI 03c2f274-bebd-457e-9b8c-4327bf5f1550 33 fields · synced Jun 6, 2026