Catalog Number

E-189

Brand Name

RUSCH

Version/Model Number

IPN046006

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BTC

Product Code Name

BAG, RESERVOIR

Public Device Record Key

458ef789-351f-40b7-af0b-c2e507c1e47f

Public Version Date

January 23, 2020

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704553703

Quantity per Package

100

Contains DI Package

04026704553709

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box