Pxp-Lavare 80121

by Thermogenesis Corp.

Pxp-Lavare 80121 is a Class II device made by Thermogenesis Corp., listed under FDA premarket submission BK120061 and listed in FDA GUDID since 1 Oct 2021 (UDI-DI 00886368000216), 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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00886368000216 UDI-DI	Date1 Oct 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK120061	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 00886368000216

Across registries

2 registries list this device

FDA premarket submission BK120061 Active
FDA GUDID UDI-DI 00886368000216 listed 1 Oct 2021 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Pxp-Lavare
Generic name: Blood centrifugation system containment kit
Model / reference: 80121

Primary DI / UDI-DI: 00886368000216
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

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Properties

Serial number
Manufacturing date

Other properties (13, all answered No)