Catalog Number

8547008

Brand Name

ISOFLOW SHEATH FLUID

Version/Model Number

8547008

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

Yes

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

-

Product Code

GIF

Product Code Name

Diluent, Blood Cell

Public Device Record Key

97d65cb7-df8f-4e9e-95fe-d9a093df46b7

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-