HeartMate™ 1050

GUDID 05415067038746

Apical Coring Knife

Thoratec Corporation

Cardiothoracic surgical procedure kit, non-medicated, single-use
Primary Device ID05415067038746
NIH Device Record Key701b1d42-15a3-469e-8416-096e5502a8c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartMate™
Version Model Number1050
Catalog Number1050
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 Batchfalse
Serial Numbertrue
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
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 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024010227 [Previous]
GS105415067038746 [Primary]

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 Date2025-05-26
Device Publish Date2025-05-16

On-Brand Devices [HeartMate™]

15415067038279ICU Cover
05415067038296ICU Cover
1541506703964114V Li-ion Battery Clip Set
0541506703904014V Li-ion Rechargeable Battery Set
05415067038746Apical Coring Knife
05415067038609Power Module Backup Battery
05415067037824Universal Battery Charger
1541506703780714V Li-ion Rechargeable Battery Set

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

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