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Insertion Set for use with Arrow(R) 5 Fr. PICC

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Ref EU-00750-45

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000236KP Basic UDI-DI 10801902199291UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902199291 UDI-DI Date9 Nov 2022ListedStatusListed 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

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2378-2026 FDA Class I initiated 21 Apr 2026

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

    • Terminated Z-1254-2020 FDA Class II initiated 20 Dec 2019

    Product lidstock contains the incorrect expiration date for the product

    • Terminated Z-2023-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

    • Terminated Z-0602-2018 FDA Class II initiated 25 Jul 2017

    Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

    • Terminated Z-0182-2018 FDA Class II initiated 1 Jun 2017

    There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

    • Terminated Z-0207-2016 FDA Class II initiated 16 Oct 2015

    Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade Name
Insertion Set for use with Arrow(R) 5 Fr. PICC EUDAMED
Arrow GUDID
Generic Name
Vascular catheterization support/maintenance kit, non-medicated
Device Name
Vascular Spring-Wire Guide Product
Model / Ref / Catalog
EU-00750-45, IPN920915
Primary DI / UDI-DI
10801902199291
Basic UDI-DI
08019020000000000000236KP
510(k) Number
FDA Product Code
LJS
EMDN Code
A018003 Needle introducers
GMDN Term
Vascular catheterization support/maintenance kit, non-medicated
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
880.5970
Medical Purpose
The Arrow guidewires are intended to facilitate the placement of central circulatory system or peripheral vascular devices for diagnostic and interventional procedures.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EU-00750-45
GUDID
IPN920915
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000023158

Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)

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Properties

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

Other properties (7)

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