Pediatric Two-Lumen CVC
by Arrow International LLC (Subsidiary of Teleflex Incorporated) 4 variants
Ref CS-14402
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08019020000000000000042K8 10801902183856 | Date26 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Central Venous Catheter (CVC) Product
- Model / Reference
- CS-14402
- Primary DI / UDI-DI
- 10801902183856
- Basic UDI-DI
- 08019020000000000000042K8
- EMDN Code
- C01020202 Central venous double-lumen catheters, non-tunneled
- Device Class
- Class III
- Medical Purpose
- The Arrow catheter is indicated to permit short-term (< 30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites Central venous pressure monitoring Total parenteral nutrition (TPN) Infusions of fluids, medications, or chemotherapy Frequent blood sampling or receiving blood transfusions/blood products Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400 psi.
Manufacturer details
- EUDAMED SRN
- US-PR-000023158
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