Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-702505

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

b49f26bb-7afb-46fa-8940-dcfec0b598cb

Public Version Date

April 27, 2018

Public Version Number

1

DI Record Publish Date

March 27, 2018

Package DI Number

40612479228106

Quantity per Package

30

Contains DI Package

20612479228096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case