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Three-Lumen CVC

by Arrow International LLC (Subsidiary of Teleflex Incorporated) United States EUDAMED

Ref SA-12703

EMDN C01020203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08019020000000000000042K8 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Central Venous Catheter (CVC) Product
Model / Reference
SA-12703
Primary DI / UDI-DI
10801902164428
Basic UDI-DI
08019020000000000000042K8
EMDN Code
C01020203 Central venous multi-lumen (>2) 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

Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 10801902164428|08019020000000000000042K8 61 fields · synced 25 Oct 2026