AccessGUDID - DEVICE: HeartMate™ (05415067037800)

GUDID

Device Identifier (DI) Information

Brand Name: HeartMate™
Version or Model: 2465
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2465
Company Name: Thoratec Corporation

Primary DI Number: 05415067037800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use
Previous DI: 00813024010692

Device Description: 14V Li-ion Rechargeable Battery Set

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?
34158	Secondary battery	A rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (assist) bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160054	000

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
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 839c03b4-0eb5-4abd-a4bb-63e0c419b2de
Public Version Date: May 26, 2025
Public Version Number: 1
DI Record Publish Date: May 16, 2025