Catalog Number

8881907199

Brand Name

Monoject

Version/Model Number

8881907199

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

cb63cc80-f6df-4e5a-b56a-8c5d89cfd09f

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-