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Two-Lumen CVC

EUDAMED

Class III (EU MDR)

Ref CS-16702

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Identity

Trade Name
Two-Lumen CVC EUDAMED
Device Name
Central Venous Catheter (CVC) Product EUDAMED
Model / Reference
CS-16702 EUDAMED

Identifiers

Primary DI / UDI-DI
10801902183610 EUDAMED
Basic UDI-DI
08019020000000000000042K8 EUDAMED
EMDN Code
C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED

Classification

Device Class
Class III EUDAMED
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. EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Category: Central venous catheterization kit, short-term

Two-Lumen CVC by Arrow International LLC (Subsidiary of Teleflex Incorporated) — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Central venous catheterization kit, short-term.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Arrow International LLC (Subsidiary of Teleflex Incorporated)
EUDAMED SRN
US-PR-000023158

Sources (1)

  • EUDAMED fbc57456-87c9-4206-9195-707e91197ae5 61 fields · synced Jul 13, 2026