Catalog Number

7-1410D-04

Brand Name

AMT Balloon G-Tube

Version/Model Number

7-1410D-04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K971434

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

5c9b980d-6085-4ede-b10c-b76f4c6e4bb1

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-