AccessGUDID - DEVICE: HeartMate 3™ (05415067038456)

GUDID

Device Identifier (DI) Information

Brand Name: HeartMate 3™
Version or Model: 105581US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105581US
Company Name: Thoratec Corporation

Primary DI Number: 05415067038456
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use
Previous DI: 00813024013266

Device Description: Sealed Outflow Graft with Bend Relief

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61747	Implantable ventricular circulatory assist system outflow cannula, animal-derived	An implantable tube which includes animal-derived materials (e.g., synthetic polymer sealed with mammalian gelatin), intended to function as an outflow for an implantable ventricular circulatory assist system, to channel blood pumped from the left ventricle into the aorta via a surgically-created anastomosis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (assist) bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160054	091

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
Handling Environment Temperature: between 0 and 35 Degrees Celsius
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 428c3d85-d617-4a67-b6b0-ec1727c05377
Public Version Date: April 17, 2025
Public Version Number: 2
DI Record Publish Date: April 07, 2025