Catalog Number

682315/A

Brand Name

RadialFlo™

Version/Model Number

10884450363956

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

1ef39c4d-b45b-463c-8df3-2c88cd865af8

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

February 28, 2019

Package DI Number

20884450363953

Quantity per Package

20

Contains DI Package

10884450363956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-