Catalog Number

IVF1010T

Brand Name

AMSafe ® Pre-Filled Normal Saline Flush Syringe

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2022

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

-

Product Code

NGT

Product Code Name

Saline, Vascular Access Flush

Public Device Record Key

06e7ca2e-a463-48f0-ae02-b305c5a3f3b9

Public Version Date

September 09, 2022

Public Version Number

2

DI Record Publish Date

April 12, 2022

Package DI Number

40704411014844

Quantity per Package

180

Contains DI Package

30704411014847

Package Discontinue Date

April 03, 2022

Package Status

Not in Commercial Distribution

Package Type

case