AccessGUDID - DEVICE: CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES (07640135140887)

GUDID

Device Identifier (DI) Information

Brand Name: CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES
Version or Model: 201-90220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201-90220
Company Name: Thoratec Switzerland GmbH

Primary DI Number: 07640135140887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486066918 *Terms of Use

Device Description: BACK-UP CONSOLE WITH BATTERIES

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33663	Cardiopulmonary bypass system centrifugal pump backup drive unit	A mains electricity (AC-powered) device, with an internal battery, that substitutes as the drive unit for a cardiopulmonary bypass system centrifugal pump to circulate blood through the extracorporeal circuit in the event of the loss of mains electricity. It typically includes monitoring and alarm functions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWA	Control, Pump Speed, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b63e1163-6b49-4dfe-99f1-d6a9d7a704be
Public Version Date: February 06, 2019
Public Version Number: 5
DI Record Publish Date: September 20, 2014