Catalog Number

00020301300

Brand Name

HemosIL ReadiPlasTin (10 mL)

Version/Model Number

00020301300

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2022

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

K122584

Product Code

GJS

Product Code Name

TEST, TIME, PROTHROMBIN

Public Device Record Key

844b8927-bec3-40f7-8bb6-89e31fd30726

Public Version Date

April 07, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-