Catalog Number

AMPFT05

Brand Name

Rospital Productos Medicos

Version/Model Number

AMPFT05

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

a3b37655-b6dc-4ea6-b8c7-daa584a437af

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Package DI Number

10812460027643

Quantity per Package

100

Contains DI Package

00812460027646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER