One-Lumen CVC
by Arrow International LLC (Subsidiary of Teleflex Incorporated) United States EUDAMED
Ref EU-04706-EN
EMDN C01020201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08019020000000000000042K8 | Date26 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Central Venous Catheter (CVC) Product
- Model / Reference
- EU-04706-EN
- Primary DI / UDI-DI
- 10801902191776
- Basic UDI-DI
- 08019020000000000000042K8
- EMDN Code
- C01020201 Central i.v. single-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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Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- EUDAMED 10801902191776|08019020000000000000042K8