Catalog Number

T11X8

Brand Name

AVANOS

Version/Model Number

13735

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

K063234,K063234

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

9223a38e-b2c3-4c4f-9117-291385d0ab8c

Public Version Date

June 18, 2020

Public Version Number

1

DI Record Publish Date

June 10, 2020

Package DI Number

10193494137356

Quantity per Package

5

Contains DI Package

00193494137359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS