Catalog Number

-

Brand Name

McKesson

Version/Model Number

MC-301

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

K905164,K905164

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

1efd8984-1ec2-4041-a37f-29c2a1288dbf

Public Version Date

June 03, 2021

Public Version Number

1

DI Record Publish Date

May 26, 2021

Package DI Number

20612479260072

Quantity per Package

10

Contains DI Package

10612479260068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box