Catalog Number

681726

Brand Name

CAREFLOW(TM) ULTRA BASIC 3 LUMEN 7FR X 200MM

Version/Model Number

681726

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

-

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

752ac8fc-f336-4129-8272-705fd4e07fcc

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

50886333617260

Quantity per Package

50

Contains DI Package

00886333617265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch