CARRYING CASE 104921

GUDID 00813024011750

Thoratec Corporation

Medical bag
Primary Device ID00813024011750
NIH Device Record Keyc9e02261-ea8b-4bb4-b34a-37a3e64f61c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARRYING CASE
Version Model Number104921
Catalog Number104921
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024011750 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-09
Device Publish Date2014-09-20

Devices Manufactured by Thoratec Corporation

15415067038279 - HeartMate™2022-09-20 ICU Cover
05415067042439 - CentriMag™2022-09-07 System Transporter
05415067038760 - HeartMate 3™2022-06-22 Coring Tool
05415067039286 - HeartMate 3™2022-06-22 Apical Cuff
05415067039361 - HeartMate 3™2022-06-22 Skin Coring Punch
15415067039481 - HeartMate 3™2022-06-22 Thread Protectors
05415067033758 - HeartMate Touch™2020-07-02 Communication System
05415067032058 - HeartMate Touch™2020-05-12 Communication System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.