Catalog Number

049730503

Brand Name

ELECTRACHROME Factor VIII

Version/Model Number

049730503

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

K981038

Product Code

GGP

Product Code Name

TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Public Device Record Key

692d5ac0-9ce6-4628-b3d7-94035ce45000

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

-