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Two-Lumen CVC

by Arrow International LLC (Subsidiary of Teleflex Incorporated) 88 variants

Ref TI-12402-ME

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08019020000000000000042K8 Basic UDI-DI 10801902170122UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Central Venous Catheter (CVC) Product
Model / Reference
TI-12402-ME
Primary DI / UDI-DI
10801902170122
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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Properties

  • Sterile