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Pxp 80065

by Thermogenesis Corp.

Pxp 80065 is a Class II device made by Thermogenesis Corp., listed under FDA premarket submission BK120061 and listed in FDA GUDID since 29 Sep 2021 (UDI-DI 00886368000636), 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) BK120061

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 Number00886368000636 UDI-DI Date29 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK120061 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK120061 Active
  • FDA GUDID UDI-DI 00886368000636 listed 29 Sep 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  • Withdrawn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
Pxp
Generic name
Blood centrifugation system containment kit
Model / reference
80065
Primary DI / UDI-DI
00886368000636
FDA product code
OAO
GMDN term
Blood centrifugation system containment kit
Device class
Class II
Regulation number
864.9900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood centrifugation system containment kit

Cleared under the same submission (BK120061)

and 8 more cleared under BK120061

Other devices from Thermogenesis Corp.

See all devices from Thermogenesis Corp. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)