Catalog Number

PM030

Brand Name

AVANOS

Version/Model Number

13536

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

88aa5f45-3af3-4eff-b9df-e40baf921215

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2020

Package DI Number

10193494135369

Quantity per Package

5

Contains DI Package

00193494135362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS