HeartMate 3™ 106532US

GUDID 15415067039481

Thread Protectors

Thoratec Corporation

Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use
Primary Device ID15415067039481
NIH Device Record Key434fac44-b7ab-4562-bacf-382de4707550
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartMate 3™
Version Model Number106532US
Catalog Number106532US
Company DUNS070156955
Company NameThoratec Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067030818 [Previous]
GS105415067039484 [Primary]
GS115415067039481 [Package]
Contains: 05415067039484
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (assist) bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-22
Device Publish Date2022-06-14

On-Brand Devices [HeartMate 3™]

05415067030269Outflow Graft Clip
15415067039481Thread Protectors
05415067039361Skin Coring Punch
05415067039286Apical Cuff
05415067038760Coring Tool

Trademark Results [HeartMate 3]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTMATE 3
HEARTMATE 3
86722375 5464938 Live/Registered
Thoratec Corporation
2015-08-12

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