Catalog Number

8881571125

Brand Name

Monoject

Version/Model Number

8881571125

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

K032438,K032438,K032438

Product Code

NGT

Product Code Name

Saline, vascular access flush

Public Device Record Key

8b89eae6-ea7c-4d53-8c4b-ea9f4c1dbf49

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

30884521005680

Quantity per Package

180

Contains DI Package

20884521005683

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE