Identity
- Trade Name
- Portex FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Model / Reference
- 11-1070 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10788942110700 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Aerosol face mask, rebreathing, single-use
Portex by Icu Medical, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 7a8c00e3-1b18-4ffd-ab3e-a39f8f9a66c2 32 fields · synced May 30, 2026