Catalog Number

PM020-N

Brand Name

AVANOS

Version/Model Number

45162

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

d7897bab-4811-41a3-836a-e59d88a88bc7

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2020

Package DI Number

10193494451629

Quantity per Package

5

Contains DI Package

00193494451622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS