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WellSky Transfusion 2021

by Wellsky Corporation

WellSky Transfusion 2021 is a Class II device made by Wellsky Corporation, listed under FDA premarket submission BK160066 and listed in FDA GUDID since 9 Feb 2021 (UDI-DI B105TRANSFUSION2021), 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) BK160066

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 NumberB105TRANSFUSION2021 UDI-DI Date9 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK160066 Date—StatusActive

Across registries

2 registries list this device

  • FDA premarket submission BK160066 Active
  • FDA GUDID UDI-DI B105TRANSFUSION2021 listed 9 Feb 2021 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
WellSky Transfusion
Generic name
Blood bank information system application software
Model / reference
2021
Primary DI / UDI-DI
B105TRANSFUSION2021
FDA product code
MMH
GMDN term
Blood bank information system application software
Device class
Class II
Regulation number
864.9165
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood bank information system application software

Cleared under the same submission (BK160066)

and 1 more cleared under BK160066

Other devices from Wellsky Corporation

See all devices from Wellsky Corporation →

Properties

  • Serial number
Other properties (14, all answered No)