Catalog Number

9912001

Brand Name

RUSCH

Version/Model Number

IPN045563

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

BTK

Product Code Name

STRAP, HEAD, GAS MASK

Public Device Record Key

2dbe8281-70d7-41cd-9ebc-159da172a592

Public Version Date

January 23, 2020

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704544671

Quantity per Package

100

Contains DI Package

04026704544677

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box