Identity
- Trade Name
- Hilo Fit FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge FDA UDI
- Model / Reference
- 11004XL FDA UDI
- Description
- Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810107330395 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
Hilo Fit by Hilo Industries LLC — 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
- Hilo Industries LLC
Sources (1)
- FDA UDI 78451d9c-dc09-489b-81b1-168ac30f1cef 33 fields · synced Jun 6, 2026