SynCardia Freedom® Power Adaptor

GUDID 00858000003268

SYNCARDIA SYSTEMS, LLC

Ventricular prosthesis system, pneumatically-powered
Primary Device ID00858000003268
NIH Device Record Keya1358604-b48e-44fa-a162-ea8800e15899
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynCardia Freedom® Power Adaptor
Version Model Number295070-001
Company DUNS080414145
Company NameSYNCARDIA SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858000003268 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

Devices Manufactured by SYNCARDIA SYSTEMS, LLC

00858000003244 - SynCardia Freedom® Car Charger2025-05-02
00858000003251 - SynCardia Freedom® Battery Charger2025-05-02
00858000003268 - SynCardia Freedom® Power Adaptor2025-05-02
00858000003268 - SynCardia Freedom® Power Adaptor2025-05-02
00858000003275 - SynCardia Freedom® Hospital AC Power Supply2025-05-02
00858000003282 - SynCardia Freedom® Home AC Power Supply2025-05-02
00858000003299 - SynCardia Freedom® Battery Charger Set Shipping Container2025-05-02
00858000003305 - SynCardia Hand Pump Shipping Container2025-05-02
00858000003015 - SynCardia Freedom® Standby Kit Shipping Container2025-05-01
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