Ortho Connect - ORTHO CONNECT™ Software is designed to collect - BIOMEDICAL DATA SOLUTIONS LIMITED

Duns Number:502054265

Device Description: ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics bl

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More Product Details

Catalog Number

-

Brand Name

Ortho Connect

Version/Model Number

3.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK190434

Product Code Details

Product Code

KSZ

Product Code Name

System, Test, Automated Blood Grouping And Antibody

Device Record Status

Public Device Record Key

92d8c6f7-696d-4952-89b2-c5307394b619

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

November 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMEDICAL DATA SOLUTIONS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6