Catalog Number

PNS-TCNC

Brand Name

NEOMED*

Version/Model Number

PNS-TCNC

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

PIF

Product Code Name

Gastrointestinal Tubes with Enteral Specific Connectors

Public Device Record Key

f8a2e87b-f89a-462f-9e03-0cf83d5027f8

Public Version Date

May 07, 2021

Public Version Number

1

DI Record Publish Date

April 29, 2021

Package DI Number

10350770000388

Quantity per Package

16

Contains DI Package

00350770000381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS