SynCardia Companion 2 Driver

GUDID 00858000003107

SYNCARDIA SYSTEMS, LLC

Artificial heart, temporary
Primary Device ID00858000003107
NIH Device Record Key6c33b8bd-d326-41d5-826e-0000a3ad9faf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynCardia Companion 2 Driver
Version Model Number397002-001
Company DUNS080414145
Company NameSYNCARDIA SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone8667719437
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100858000003107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOZArtificial Heart

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

Devices Manufactured by SYNCARDIA SYSTEMS, LLC

00858000003008 - SynCardia temporary Total Artificial Heart System2018-07-06
00858000003077 - SynCardia Companion Rechargeable LI-ION Battery2018-07-06
00858000003084 - SynCardia Freedom® Onboard Battery2018-07-06
00858000003107 - SynCardia Companion 2 Driver 2018-07-06
00858000003107 - SynCardia Companion 2 Driver 2018-07-06
00858000003114 - SynCardia Hand Pump2018-07-06
00858000003121 - SynCardia Freedom® Driver2018-07-06

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