Catalog Number

00020008900

Brand Name

HemosIL Antithrombin

Version/Model Number

00020008900

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2020

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

K070301

Product Code

JBQ

Product Code Name

ANTITHROMBIN III QUANTITATION

Public Device Record Key

d73d5cdb-8e0c-45fa-9b01-758e04120fb7

Public Version Date

July 13, 2021

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

-