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Logic 4.0

by Csl Plasma, Inc.

Logic 4.0 is a Class II device made by Csl Plasma, Inc., listed under FDA premarket submission BK120002 and listed in FDA GUDID since 13 Aug 2021 (UDI-DI 00860007397608), active as of 22 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 22 Oct 2026

Documents

510(k) BK120002

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860007397608 UDI-DI Date13 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK120002 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK120002 Active
  • FDA GUDID UDI-DI 00860007397608 listed 13 Aug 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  • Withdrawn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
Logic
Generic name
Blood bank information system application software
Model / reference
4.0
Primary DI / UDI-DI
00860007397608
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

Other devices from Csl Plasma, Inc.

  • Adims 1.0

    Class II

Properties

  • Single use
Other properties (14, all answered No)