WellSky Blood - Emergency Issue - WellSky™ Blood – Emergency Issue 2020 R1 is a - WELLSKY CORPORATION

Duns Number:177240249

Device Description: WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS)

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More Product Details

Catalog Number

-

Brand Name

WellSky Blood - Emergency Issue

Version/Model Number

2020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Device Record Status

Public Device Record Key

d82139ee-c191-4d4f-9032-676cdf7bb660

Public Version Date

June 23, 2020

Public Version Number

1

DI Record Publish Date

June 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLSKY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8