Catalog Number

-

Brand Name

NeoDevices, Inc.

Version/Model Number

ND-S5EL

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"

-

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

FPD

Product Code Name

Tube, Feeding

Public Device Record Key

c51957d9-78c7-4abf-a9de-ef96c7b24fa7

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10816340027846

Quantity per Package

100

Contains DI Package

10816340023015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-