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Mix2Vial Transfer Device 8074017

by West Pharma. Services Il, . Ltd

Mix2Vial Transfer Device 8074017 is a Class II device made by West Pharma. Services Il, . Ltd, cleared under FDA 510(k) K031861 on 29 Jul 2003 and listed in FDA GUDID since 1 May 2016 (UDI-DI 07290108240535), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K031861

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290108240535 UDI-DI Date1 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031861 Date29 Jul 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031861 decided 29 Jul 2003 Active
  • FDA GUDID UDI-DI 07290108240535 listed 1 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031861
  2. Listed FDA GUDID 07290108240535

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mix2Vial Transfer Device
Generic name
Medication transfer needle, filtering
Model / reference
8074017
Primary DI / UDI-DI
07290108240535
510(k) Number
FDA product code
LHI
GMDN term
Medication transfer needle, filtering
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

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Other devices filed under Medication transfer needle, filtering.

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Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)