WellSky Corporation. - Headquarters

FDA Device Registration & Listing · Overland Park, KS, US · Registration 3006129391

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006129391
FEI Number
3006129391
Entity Name
WellSky Corporation. - Headquarters
City/State/Country
Overland Park, KS, US
Establishment Address
11300 Switzer Road, --, Overland Park, KS 66210, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
WellSky Corporation (Owner Number: 9010846)
Owner / Operator Contact Address
11300 Switzer Road, --, Overland Park, KS 66210, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK230826
PMA Number
N/A

All Registered Proprietary Names

WellSky Blood-Emergency Issue 2020 R1 WellSky Transfusion 2015R2 HCLL Transfusion 2015R2 LifeTrak2012 WellSky Transfusion 2022 R3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2020-09-16
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2016-10-31
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2012-10-11
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2023-12-06

Official Correspondent

David Stevens

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WellSky Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006129391. Last updated year: 2026. Please use registration number 3006129391 when referencing this establishment in official correspondence.
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