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Arrowg+ard Blue(R) Five-Lumen CVC

EUDAMED

Class III (EU MDR)

Ref DE-25855S-AGK

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Identity

Trade Name
Arrowg+ard Blue(R) Five-Lumen CVC EUDAMED
Device Name
AGB CVC Procedure Pack EUDAMED
Model / Reference
DE-25855S-AGK EUDAMED

Identifiers

Primary DI / UDI-DI
10801902165678 EUDAMED
Basic UDI-DI
08019020000000000000044KC EUDAMED
EMDN Code
C01020203 CENTRAL VENOUS MULTI-LUMEN (>2) 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

Arrowg+ard Blue(R) Five-Lumen CVC by Arrow International LLC (Subsidiary of Teleflex Incorporated) — Class III — MDR — listed in EUDAMED

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

EUDAMED SRN
US-PR-000023158

Sources (1)

  • EUDAMED aa9e3a5a-a07b-4d0f-b399-2c2478063b28 61 fields · synced Jul 28, 2026