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Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC pre-loaded with Arrow(R) NaviCurve(TM) Stylet

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Ref IDLX-45541-CURV

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000050K7 Basic UDI-DI 10801902222142UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902222142 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Not listed: EUDAMED names no country where this device is made available.

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

Last checked 28 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC pre-loaded with Arrow(R) NaviCurve(TM) Stylet EUDAMED
Arrow GUDID
Generic Name
Peripherally-inserted central venous catheter
Device Name
Arrowg+ard Blue Advance (AGBA) Peripherally Inserted Central Catheter (PICC) Product
Model / Ref / Catalog
IDLX-45541-CURV, IPN930603
Primary DI / UDI-DI
10801902222142
Basic UDI-DI
08019020000000000000050K7
510(k) Number
FDA Product Code
LJS
EMDN Code
C01020101 Central i.v. single-lumen catheters, peripheral access
GMDN Term
Peripherally-inserted central venous catheter
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
880.5970
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.
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IDLX-45541-CURV
GUDID
IPN930603
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000023158

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No