Catalog Number

00020011700

Brand Name

HemosIL Factor VII Deficient Plasma (10 X 1 mL)

Version/Model Number

00020011700

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

K024082,K024082

Product Code

GJT

Product Code Name

PLASMA, COAGULATION FACTOR DEFICIENT

Public Device Record Key

15f91ab0-674c-4f0f-8ff2-12f507882bc7

Public Version Date

July 13, 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

-