Catalog Number

PNM-60ENEN

Brand Name

NeoMed Enteral Extension Set

Version/Model Number

PNM-60ENEN

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

828a1654-6f81-4b3e-8ee9-1b5078082fc3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

20817584012879

Quantity per Package

8

Contains DI Package

10817584012872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper