Catalog Number

IVF1205SS

Brand Name

AMSafe® Pre-Filled Normal Saline Flush Syringe

Version/Model Number

1

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

-

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

-

FDA Premarket Submission

K183473,K183473,K183473,K183473

Product Code

NGT

Product Code Name

Saline, Vascular Access Flush

Public Device Record Key

60b0f96d-e852-4c0a-8aec-748a6bfbf94f

Public Version Date

September 09, 2022

Public Version Number

2

DI Record Publish Date

February 10, 2020

Package DI Number

10704411009986

Quantity per Package

1

Contains DI Package

00704411009989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch