AccessGUDID - DEVICE: HeartMate™ (05415067038234)

GUDID

Device Identifier (DI) Information

Brand Name: HeartMate™
Version or Model: 107754
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 107754
Company Name: Thoratec Corporation

Primary DI Number: 05415067038234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use
Previous DI: 00813024010883

Device Description: Mobile Power Unit

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?
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (assist) bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P060040	000
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
Handling Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab6c90a4-a666-47ae-aa4f-68a7120e2dbd
Public Version Date: April 01, 2024
Public Version Number: 1
DI Record Publish Date: March 22, 2024