Catalog Number

PNM-TCNC

Brand Name

NEOMED*

Version/Model Number

PNM-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

19b3c3aa-3b04-4200-9965-5a30d90eba70

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Package DI Number

20350770000378

Quantity per Package

16

Contains DI Package

10350770000371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS