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Vial Adapter 8070105

by West Pharma. Services Il, . Ltd

Vial Adapter 8070105 is a Class II device made by West Pharma. Services Il, . Ltd, cleared under FDA 510(k) K001293 on 5 May 2000 and listed in FDA GUDID since 1 May 2016 (UDI-DI 07290108240788), 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) K001293

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 Number07290108240788 UDI-DI Date1 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK001293 Date5 May 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001293 decided 5 May 2000 Active
  • FDA GUDID UDI-DI 07290108240788 listed 1 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001293
  2. Listed FDA GUDID 07290108240788

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vial Adapter
Generic name
Vial/bottle adaptor, non-hermetic
Model / reference
8070105
Primary DI / UDI-DI
07290108240788
510(k) Number
FDA product code
LHI
GMDN term
Vial/bottle adaptor, non-hermetic
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Similar devices in this category

Other devices filed under Vial/bottle adaptor, non-hermetic.

Other devices from West Pharma. Services IL, Ltd.

See all devices from West Pharma. Services IL, Ltd. →

Properties

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