AccessGUDID - DEVICE: Thoratec® HeartMate 3™ (00813024013075)

GUDID

Device Identifier (DI) Information

Brand Name: Thoratec® HeartMate 3™
Version or Model: 10005872
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10005872
Company Name: Thoratec Corporation

Primary DI Number: 00813024013075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use

Device Description: Coring Tool

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?
61371	Cardiothoracic surgical procedure kit, non-medicated, single-use	A collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (assist) bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160054	005

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 30 Degrees Celsius
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1bcf35d0-3bf4-4a6c-9d9b-cd3c83f2325b
Public Version Date: December 05, 2019
Public Version Number: 3
DI Record Publish Date: October 19, 2018