AccessGUDID - DEVICE: HeartMate II®, System Controller (00813024012528)

GUDID

Device Identifier (DI) Information

Brand Name: HeartMate II®, System Controller
Version or Model: 105109
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105109
Company Name: Thoratec Corporation

Primary DI Number: 00813024012528
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use

Device Description: System Controller

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:	Yes
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?
37315	Implantable ventricular circulatory assist system control unit	An electrically-powered external component of an implantable ventricular circulatory assist system intended to supply power to the implanted system pump via a percutaneous lead (not included). It is typically a belt worn device used as a bridge to transplantation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (Assisst) 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe023fe6-a8f2-4564-b2ae-53a3ab6d988f
Public Version Date: February 05, 2021
Public Version Number: 6
DI Record Publish Date: April 13, 2015