Catalog Number

-

Brand Name

Rem Systems

Version/Model Number

B 898

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

59ea9a0c-0475-4a89-a15c-56a45679704b

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Package DI Number

00897891001588

Quantity per Package

1

Contains DI Package

10897891001585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-