Merge Hemo - MERGE HEALTHCARE SOLUTIONS INC.

Duns Number:065626069

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More Product Details

Catalog Number

-

Brand Name

Merge Hemo

Version/Model Number

9.4

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

K152864

Product Code Details

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Device Record Status

Public Device Record Key

55bfdfca-b777-40d9-b119-32f6c8447f3e

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERGE HEALTHCARE SOLUTIONS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65