Catalog Number

401SE

Brand Name

Monoject

Version/Model Number

401SE

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

PNR

Product Code Name

Enteral Syringes with enteral specific connectors

Public Device Record Key

96eb0f3f-0b1a-4921-a359-353aad9afa51

Public Version Date

October 29, 2021

Public Version Number

10

DI Record Publish Date

September 24, 2016

Package DI Number

30884521512836

Quantity per Package

240

Contains DI Package

10884521512832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE