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22mm Smoothbore Bilevel Breathing System Swivel Co2 Leak Port Monitoring Line
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- 22MM SMOOTHBORE BILEVEL BREATHING SYSTEM SWIVEL CO2 LEAK PORT MONITORING LINE FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- 22MM SMOOTHBORE BILEVEL BREATHING SYSTEM WITH SWIVEL CO2 LEAK PORT AND MONITORING LINE. 1.8M FDA UDI
- Model / Reference
- 5805031 FDA UDI
- Description
- 22MM SMOOTHBORE BILEVEL BREATHING SYSTEM WITH SWIVEL CO2 LEAK PORT AND MONITORING LINE. 1.8M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267157839 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
Yes
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
No
FDA UDI
Category: Ventilator breathing circuit, single-use
22mm Smoothbore Bilevel Breathing System Swivel Co2 Leak Port Monitoring Line by Intersurgical Incorporated — 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
- Intersurgical Incorporated
Sources (1)
- FDA UDI a1ad1f08-5f48-47aa-b835-4d750b53a986 34 fields · synced May 30, 2026