AccessGUDID - DEVICE: THORATEC® HEARTMATE®, SYSTEM MONITOR (00813024010852)

GUDID

Device Identifier (DI) Information

Brand Name: THORATEC® HEARTMATE®, SYSTEM MONITOR
Version or Model: 1286A-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1286A-US
Company Name: Thoratec Corporation

Primary DI Number: 00813024010852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use

Device Description: SYSTEM MONITOR

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:	Yes
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?
36612	Image display unit, colour	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 064b672a-1c01-471f-91b8-b0f82a58aa07
Public Version Date: May 03, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2014