Wellsky Corp

FDA Filings

This page includes the latest FDA filings for Wellsky Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006129391
• FEI Number: 3006129391
• Name: WellSky Corporation. - Headquarters
• Owner & Operator: WellSky Corporation
• Contact Address: 11300 Switzer Road --; Overland Park KS 66210 US
• Official Correspondent:
  • Jon C Moeckel
  • x-913-3071051-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11300 Switzer Road --; Overland Park, KS 66210 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID B105TRANSFUSION20240 WELLSKY CORPORATION	WellSky Transfusion	2023-12-22
GUDID B105TRANSFUSION2023 WELLSKY CORPORATION	WellSky Transfusion	2023-12-14
GUDID B105LIFETRAK0 WELLSKY CORPORATION	LifeTrak	2023-06-20
GUDID B105HCLL0 WELLSKY CORPORATION	HCLL	2023-06-20
GUDID B105BLOODCENTERS2018 WELLSKY CORPORATION	WellSky Blood Centers	2023-06-20
GUDID B105BLOODCENTERS2023 WELLSKY CORPORATION	WellSky Blood Centers	2023-05-22
GUDID B105TRANSFUSION0 WELLSKY CORPORATION	WellSky Transfusion	2022-02-18
GUDID B105BLOODCENTERS0 WELLSKY CORPORATION	WellSky Blood Centers	2022-02-18
GUDID B105TRANSFUSION2021 WELLSKY CORPORATION	WellSky Transfusion	2021-02-17
GUDID B105TRANSFUSION2020 WELLSKY CORPORATION	WellSky Transfusion	2021-02-17
GUDID B105BLOOD2020 WELLSKY CORPORATION	WellSky Blood - Emergency Issue	2020-06-23
PMN BK200479 WellSky Corporation	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2020-06-12
GUDID B105TRANSFUSION20190 WELLSKY CORPORATION	WellSky Transfusion	2020-04-06
GUDID B105TRANSFUSION20180 WELLSKY CORPORATION	WellSky Transfusion	2020-04-06
GUDID B105BLOODCENTERS2019 WELLSKY CORPORATION	WellSky Blood Centers	2020-04-06
PMN BK180200 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	WellSky Blood Centers 2018	2018-09-05
PMN BK180200 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak 2018	2018-09-05
PMN BK160066 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	WellSky Transfusion 2015R2	2016-10-31
PMN BK160066 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	HCLL Transfusion 2015R2	2016-10-31
PMN BK120039 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak2012	2012-10-11
PMN BK120036 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	HCLL2012	2012-10-11
PMN BK100069 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak/Plasma	2012-01-18
PMN BK100057 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak/Lab and Distribution	2012-01-18
PMN BK100043 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak	2012-01-18
PMN BK060019 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak/Donor 3.01	2007-11-07
PMN BK050011 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak/Lab and Distribution	2007-11-07
PMN BK030078 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak (tm) Donor 3.01	2007-11-07
PMN BK010052 | MMH WellSky Corporation. - Headquarters [WellSky Corporation]	LifeTrak	2007-11-07

Related Finance Registrations

NCAGE Code	44GB6	WELLSKY CORPORATION
CAGE Code	44GB6	WELLSKY CORPORATION
S.A.M. Registration	44GB6 [177240249]	WELLSKY CORPORATION