Catalog Number

01-PN-015

Brand Name

Nose It All

Version/Model Number

01-PN-015

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EMX

Product Code Name

Balloon, Epistaxis

Public Device Record Key

e1f57a03-9d74-4c70-a01b-c2a4cab57844

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Package DI Number

00860006794743

Quantity per Package

3

Contains DI Package

00860006794712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-