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Na Pik 150

by Maquet Cardiopulmonary AG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

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 Number04037691730677 UDI-DIDate4 Nov 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3144-2026 FDA Class II initiated 31 Jul 2026
    • Ongoing Z-3145-2026 FDA Class II initiated 31 Jul 2026
    • Ongoing Z-3146-2026 FDA Class II initiated 31 Jul 2026

    The packaging may not consistently maintain sterile barrier integrity.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
PIK 150, 70105.3069
Primary DI / UDI-DI
04037691730677
510(k) Number
FDA Product Code
DWF
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K131666)

Other devices from Maquet Cardiopulmonary AG

See all devices from Maquet Cardiopulmonary AG →

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