Catalog Number

MIS-1130

Brand Name

Normal Saline IV Flush Syringe

Version/Model Number

10mL in 12mL syringe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K091583,K091583,K091583

Product Code

NGT

Product Code Name

Saline, Vascular Access Flush

Public Device Record Key

365914fe-24bb-4de7-a774-454e102e20c4

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

April 21, 2016

Package DI Number

50364253000305

Quantity per Package

16

Contains DI Package

30364253111304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box