Identity
- Trade Name
- Patient Circuit Kit FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Model / Reference
- Patient Circuit Kit FDA UDI
Identifiers
- Catalog Number
- 91-101-US304 FDA UDI
- Primary DI / UDI-DI
- 00850057117172 FDA UDI
- 510(k) Number
- K241135 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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: Ventilator breathing circuit, single-use
Patient Circuit Kit by Corvent Medical, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K241135 also covers:
- BV Filters — CORVENT MEDICAL, INC
- Cart, Accessory Bar — CORVENT MEDICAL, INC
- Cart, Display Bracket — CORVENT MEDICAL, INC
- Cart, Display Mount — CORVENT MEDICAL, INC
- Cart, Humidifier Mount — CORVENT MEDICAL, INC
- Cart, IV Pole — CORVENT MEDICAL, INC
- Cart, IV Pole Mount — CORVENT MEDICAL, INC
- Cart, Nebulizer Mount — CORVENT MEDICAL, INC
- Circuit Arm — CORVENT MEDICAL, INC
- Exhalation Valve — CORVENT MEDICAL, INC
- Flow Sensor Cable — CORVENT MEDICAL, INC
- Flow Sensors — CORVENT MEDICAL, INC
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
- Corvent Medical, Inc
Sources (1)
- FDA UDI 1e982240-a035-46f1-9628-a7a547d3ed1b 35 fields · synced May 30, 2026