Sanguin Liberty SRIMPORT - The Liberty SRIMPORT software is an interface - BIOMEDICAL DATA SOLUTIONS LIMITED

Duns Number:502054265

Device Description: The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality t The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.

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More Product Details

Catalog Number

-

Brand Name

Sanguin Liberty SRIMPORT

Version/Model Number

3.1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK100030

Product Code Details

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Device Record Status

Public Device Record Key

cdcd7919-322f-46f6-a99b-71e1e8959fc1

Public Version Date

November 16, 2020

Public Version Number

2

DI Record Publish Date

October 29, 2018

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