Catalog Number

-

Brand Name

Merge Hemo

Version/Model Number

11.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2021

Issuing Agency

In GS1

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

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

58250c79-ad78-4741-9ee0-16c3e71f595f

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-