Catalog Number

681701/A

Brand Name

Careflow™

Version/Model Number

10884450357887

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

FOZ

Product Code Name

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

Public Device Record Key

800ba3ac-2c01-4938-a10e-0faad7a75cc0

Public Version Date

December 13, 2021

Public Version Number

3

DI Record Publish Date

February 24, 2019

Package DI Number

20884450357884

Quantity per Package

10

Contains DI Package

10884450357887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-