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Arrow IPN030127

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902009101 UDI-DI Date5 Jun 2018ListedStatusListed 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  • Withdrawn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
Central venous catheterization kit, short-term
Model / Ref / Catalog
IPN030127, CS-22854-E
Primary DI / UDI-DI
10801902009101
510(k) Number
FDA Product Code
FOZ
GMDN Term
Central venous catheterization kit, short-term
Device Class
Class II
Regulation Number
880.5200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Central venous catheterization kit, short-termCentrally-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
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

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