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Arrow IPN030911

by Teleflex Incorporated 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801902057044 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1497-2009 FDA Unclassified (pre-2012) initiated 11 Feb 2009

    Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Arrow
Generic Name
Centrally-inserted central venous catheter
Model / Ref / Catalog
IPN030911, CV-20854
Primary DI / UDI-DI
00801902057044
510(k) Number
FDA Product Code
FOZ
GMDN Term
Centrally-inserted central venous catheter
Device Class
Class II
Regulation Number
880.5200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Centrally-inserted central venous catheter

Cleared under the same submission (K962577)

Show all (12)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

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