Catalog Number

-

Brand Name

CircuCool™ 8005 Pump

Version/Model Number

M0048005R0

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

-

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

P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

e9ccaf85-4772-471f-af46-fed22b6a6acf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-