Catalog Number

-

Brand Name

Q2 Low Pressure Power Injection Extension Set w/Swab

Version/Model Number

95907

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

78781967-53dc-4a70-a002-8609ac505a2e

Public Version Date

December 28, 2018

Public Version Number

1

DI Record Publish Date

November 27, 2018

Package DI Number

20634624959075

Quantity per Package

100

Contains DI Package

00634624959071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-