Catalog Number

8881907003

Brand Name

Monoject

Version/Model Number

8881907003

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KYW

Product Code Name

CONTAINER, LIQUID MEDICATION, GRADUATED

Public Device Record Key

2e0e2939-a2f7-4d3e-95da-bfb8482ef5b0

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Package DI Number

20884521014630

Quantity per Package

500

Contains DI Package

10884521014633

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE