Catalog Number

8881570300

Brand Name

Monoject

Version/Model Number

8881570300

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

57a4dcdb-cc87-4c24-b69d-38c0e835b8eb

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884521005631

Quantity per Package

20

Contains DI Package

30884521005635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK