Catalog Number

95714

Brand Name

Q2 Low Pressure Power Injection Extension Set

Version/Model Number

95714

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

K162804,K162804

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

f390bfbe-2ad5-456d-98d9-5ea9a0d5ce2b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 27, 2017

Package DI Number

20634624957149

Quantity per Package

100

Contains DI Package

00634624957145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper