Catalog Number

08742000

Brand Name

COMPAT®

Version/Model Number

N/A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 11, 2019

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

K885339,K885339

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

8168c570-938c-4a31-807e-c3c9ac72400d

Public Version Date

April 20, 2020

Public Version Number

6

DI Record Publish Date

October 16, 2015

Package DI Number

20043900950710

Quantity per Package

5

Contains DI Package

10043900950706

Package Discontinue Date

January 11, 2019

Package Status

Not in Commercial Distribution

Package Type

Box