Expanse Blood Bank - MEDITECH's Blood Bank Software is a Blood - MEDICAL INFORMATION TECHNOLOGY, INC.

Duns Number:065152530

Device Description: MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightl MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges.

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More Product Details

Catalog Number

-

Brand Name

Expanse Blood Bank

Version/Model Number

Expanse

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"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

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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

c9b50371-41bf-4619-8332-05b473d328ae

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL INFORMATION TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3