Catalog Number

GJ-1422

Brand Name

TubeClear

Version/Model Number

GJ-1422

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

K200646,K200646,K200646

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

a74270e4-c695-46a2-a381-91a7ea42c22b

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Package DI Number

10850458007000

Quantity per Package

5

Contains DI Package

00850458007003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton