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Vamp Plus VP2

by Becton, Dickinson and Company

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K181684; other models may be affected

Documents

510(k) K181684

FDA submission, from GUDID

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 Number00885403523833 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181684 Date8 Nov 2018DecidedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0414-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K181684

    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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Vamp Plus
Generic name
Arterial blood sampling kit
Model / Ref / Catalog
VP2
Primary DI / UDI-DI
00885403523833
510(k) Number
FDA product code
KRA
GMDN term
Arterial blood sampling kit
Device class
Class II
Regulation number
870.1210
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 150 Centimeter

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No