Catalog Number

FTL5.0P-EO

Brand Name

NEOMED*

Version/Model Number

FTL5.0P-EO

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

-

Product Code

BSS

Product Code Name

TUBE, NASOGASTRIC

Public Device Record Key

d7287c3c-2913-466c-a523-c28b0a22c68d

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

20350770002266

Quantity per Package

16

Contains DI Package

10350770002269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS