Identity
- Trade Name
- Portex FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Model / Reference
- C3719350 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688418562 FDA UDI
- FDA Product Code
- BTC FDA UDIBSJ FDA UDIBYD FDA UDICAI FDA UDICAH FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5320 FDA UDI868.5550 FDA UDI868.5375 FDA UDI868.5240 FDA UDI868.5260 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia breathing circuit, single-use
Portex by Icu Medical, Inc. — 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
- Icu Medical, Inc.
Sources (1)
- FDA UDI 77439476-ce08-40b1-b730-3499adab61e5 32 fields · synced May 30, 2026