Catalog Number

-

Brand Name

e-Delphyn LIS Donor

Version/Model Number

21.x.x (US)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK200513

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Public Device Record Key

59ea0634-b5c8-45d4-a6e2-3f630f8a7dab

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

August 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-