HeartMate™ GoGear™ 104230

GUDID 05415067039804

Holster Vest Medium

Thoratec Corporation

Personal device holder, reusable
Primary Device ID05415067039804
NIH Device Record Keyfddfa4a4-e782-435c-905c-6a9c7fb55938
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartMate™ GoGear™
Version Model Number104230
Catalog Number104230
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
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
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024011125 [Previous]
GS105415067039804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (assist) bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

On-Brand Devices [HeartMate™ GoGear™]

05415067039828Holster Vest Large
05415067039804Holster Vest Medium
05415067038173Shower Bag

Trademark Results [HeartMate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTMATE
HEARTMATE
76307678 not registered Dead/Abandoned
Thoratec Corporation
2001-08-31
HEARTMATE
HEARTMATE
73701099 1496671 Live/Registered
THERMEDICS INC.
1987-12-14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.