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

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05415067039446 - HeartMate 3™2025-07-29 System Controller
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05415067039903 - HeartMate™ GoGear™2025-07-29 Wearable Accessories Kit
05415067039422 - HeartMate 3™2025-07-24 System Controller Low Flow 2.0
15415067037807 - HeartMate™2025-05-26 14V Li-ion Rechargeable Battery Set
05415067037824 - HeartMate™2025-05-26 Universal Battery Charger
05415067038173 - HeartMate™ GoGear™2025-05-26 Shower Bag

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