Catalog Number

-

Brand Name

McKesson

Version/Model Number

2165

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

K953252,K953252,K953252

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

115052cc-8dba-4690-9fa3-58e4429b05e9

Public Version Date

November 29, 2018

Public Version Number

4

DI Record Publish Date

June 29, 2017

Package DI Number

40612479195507

Quantity per Package

20

Contains DI Package

20612479195497

Package Discontinue Date

December 31, 2017

Package Status

Not in Commercial Distribution

Package Type

Case