Catalog Number

-

Brand Name

Rem Systems

Version/Model Number

B 860SC

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

a756ce7b-f1f0-43bf-ab11-9f8d4438be0d

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 31, 2020

Package DI Number

00813153025406

Quantity per Package

1

Contains DI Package

10813153025403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-