Catalog Number

8881590125

Brand Name

Monoject

Version/Model Number

8881590125

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

e1e6dcb4-4bae-48a9-bbd7-839df3602bfb

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884521005850

Quantity per Package

30

Contains DI Package

10884521005853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK