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Acp 215 50042-00

by Haemonetics Corporation

Acp 215 50042-00 is a Class II device made by Haemonetics Corporation, listed under FDA premarket submission BK060008 and listed in FDA GUDID since 2 May 2017 (UDI-DI 30812747015183), 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) BK060008

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 Number30812747015183 UDI-DI Date2 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK060008 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK060008 Active
  • FDA GUDID UDI-DI 30812747015183 listed 2 May 2017 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acp 215
Generic name
Blood cell freeze/thaw system
Model / reference
50042-00
Primary DI / UDI-DI
30812747015183
FDA product code
KSW
GMDN term
Blood cell freeze/thaw system
Device class
Class II
Regulation number
864.9145
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood cell freeze/thaw system

Cleared under the same submission (BK060008)

and 1 more cleared under BK060008

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)