Bio-Medicus® - CANN CB96345-027 BIO-MED 27FR - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CANN CB96345-027 BIO-MED 27FR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Bio-Medicus®

Version/Model Number

CB96345-027

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 25, 2017

Issuing Agency

In GS1

Product Characteristics

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

Yes

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

-

FDA Premarket Submission

K924642

Product Code Details

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

45cf38e3-8d47-4aef-91e9-c267faa289e0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601