Catalog Number

-

Brand Name

RiverPass

Version/Model Number

PN-004

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HWQ

Product Code Name

Passer

Public Device Record Key

aef70669-34ce-4a83-a0fa-27cde006e607

Public Version Date

July 14, 2022

Public Version Number

1

DI Record Publish Date

July 06, 2022

Package DI Number

10840277401783

Quantity per Package

12

Contains DI Package

00840277401786

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-