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Truwave PXMK2147

by Becton, Dickinson and Company

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K171996; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885403526469 UDI-DI Date16 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0413-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K171996

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Truwave
Generic Name
Invasive-pressure external transducer, single-use
Model / Ref / Catalog
PXMK2147
Primary DI / UDI-DI
00885403526469
510(k) Number
FDA Product Code
DXO
GMDN Term
Invasive-pressure external transducer, single-use
Device Class
Class II
Regulation Number
870.2870
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K171996)

Show all (12)

Other devices from Becton, Dickinson and Company

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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