Catalog Number

-

Brand Name

REM

Version/Model Number

BC 2148

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

c583bab5-38f9-4312-a2ba-e0d145455348

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

00813153026502

Quantity per Package

1

Contains DI Package

10813153026509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-