Catalog Number

ACC05

Brand Name

AVANOS

Version/Model Number

13542

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051401,K051401

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

487b2a9a-3701-4403-9080-86320b9135cb

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 11, 2020

Package DI Number

10193494135420

Quantity per Package

5

Contains DI Package

00193494135423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS