Catalog Number

TBT03

Brand Name

Halyard

Version/Model Number

40790

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

K073187,K073187

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

028d7e9a-45a9-4954-a1ea-baad676d2a05

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

August 10, 2016

Package DI Number

30680651407901

Quantity per Package

5

Contains DI Package

10680651407907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS