Catalog Number

00008468600

Brand Name

HemosIL ProClot Diluent

Version/Model Number

00008468600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K070635

Product Code

GGP

Product Code Name

TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Public Device Record Key

f3701d3d-383d-406c-a988-9a1150f10838

Public Version Date

July 14, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-