Catalog Number

ONQEXT

Brand Name

ON-Q*

Version/Model Number

ONQEXT

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)

Yes

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

0ce81b4d-2ee0-4606-8cd1-484ad8b62f26

Public Version Date

April 22, 2021

Public Version Number

1

DI Record Publish Date

April 14, 2021

Package DI Number

10193494471863

Quantity per Package

5

Contains DI Package

00193494471866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS