Catalog Number

PNM-S12EO

Brand Name

NEOMED*

Version/Model Number

PNM-S12EO

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

FMF

Product Code Name

Syringe, piston

Public Device Record Key

d0fe7c0c-2489-47c5-846d-494d30a75f89

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

May 13, 2021

Package DI Number

10350770002719

Quantity per Package

200

Contains DI Package

00350770002712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS