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Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC pre-loaded with Arrow(R) VPS TipTracker(TM) Stylet

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Ref PR-45552-TTS

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 Number08019020000000000000050K7 Basic UDI-DI 10801902197822UDI-DIDate20 Aug 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  • Withdrawn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
Arrowg+ard Blue Advance (AGBA) Peripherally Inserted Central Catheter (PICC) Product
Model / Reference
PR-45552-TTS
Primary DI / UDI-DI
10801902197822
Basic UDI-DI
08019020000000000000050K7
EMDN Code
C01020102 Central i.v. multi-lumen catheters, peripheral access
Device Class
Class III
Medical Purpose
The Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Pressure Injectable PICC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate ranges from 4 mL/sec to 6 mL/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection. Arrowg+ard Blue Advance Protection treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods, and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

Manufacturer details

EUDAMED SRN
US-PR-000023158

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Properties

  • Sterile