Thorate® VAD, Surgical Implant Accessory Kit 20002-2615-001

GUDID 00813024013129

Thoratec Corporation

Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use
Primary Device ID00813024013129
NIH Device Record Key82420577-e995-428d-9103-9b4185b5b2a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameThorate® VAD, Surgical Implant Accessory Kit
Version Model Number20002-2615-001
Catalog Number20002-2615-001
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Operating and Storage Conditions

Storage 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
GS100813024013129 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-16
Device Publish Date2014-09-20

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