Catalog Number

157200190

Brand Name

RUSCH

Version/Model Number

IPN029672

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

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Public Device Record Key

cdd7128a-7a8d-42b2-a3d8-fe9e4cbac508

Public Version Date

January 20, 2021

Public Version Number

5

DI Record Publish Date

July 24, 2019

Package DI Number

34026704662594

Quantity per Package

10

Contains DI Package

14026704662590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box