Catalog Number

SEN12TPWCP

Brand Name

CARDINAL HEALTH

Version/Model Number

SEN12TPWCP

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"

Yes

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

OGW

Product Code Name

Tracheostomy kit

Public Device Record Key

c1278436-44a1-4d46-9a47-17128d321e4a

Public Version Date

July 20, 2018

Public Version Number

3

DI Record Publish Date

December 06, 2017

Package DI Number

50887488872061

Quantity per Package

2

Contains DI Package

10887488872063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE