Change Healthcare Cardiology Hemo - CHANGE HEALTHCARE ISRAEL LTD

Duns Number:600748180

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More Product Details

Catalog Number

-

Brand Name

Change Healthcare Cardiology Hemo

Version/Model Number

14.1.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K131497

Product Code Details

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Device Record Status

Public Device Record Key

a1bcae5f-6f8a-471c-bf8e-a29887b1cd48

Public Version Date

December 24, 2018

Public Version Number

1

DI Record Publish Date

November 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

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