Catalog Number

00020301400

Brand Name

HemosIL ReadiPlasTin (20 mL)

Version/Model Number

00020301400

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

K122584

Product Code

GJS

Product Code Name

TEST, TIME, PROTHROMBIN

Public Device Record Key

91c2cf1c-37cb-4ba4-8d4e-1c5fe4023c02

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

-