SynCardia Freedom® Onboard Battery

GUDID 00858000003084

SYNCARDIA SYSTEMS, LLC

Artificial heart, temporary

Primary Device ID	00858000003084
NIH Device Record Key	e03ae64d-08a7-48b2-a2f1-1109ee031d8c
Commercial Distribution Status	In Commercial Distribution
Brand Name	SynCardia Freedom® Onboard Battery
Version Model Number	295025-001
Company DUNS	080414145
Company Name	SYNCARDIA SYSTEMS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx
Phone	8667719437
Email	xx@xx.xx

Operating and Storage Conditions

Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858000003084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P030011

FDA Product Code

LOZ	Artificial Heart

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-23

Devices Manufactured by SYNCARDIA SYSTEMS, LLC

00858000003244 - SynCardia Freedom® Car Charger	2025-05-02
00858000003251 - SynCardia Freedom® Battery Charger	2025-05-02
00858000003268 - SynCardia Freedom® Power Adaptor	2025-05-02
00858000003275 - SynCardia Freedom® Hospital AC Power Supply	2025-05-02
00858000003282 - SynCardia Freedom® Home AC Power Supply	2025-05-02
00858000003299 - SynCardia Freedom® Battery Charger Set Shipping Container	2025-05-02
00858000003305 - SynCardia Hand Pump Shipping Container	2025-05-02
00858000003015 - SynCardia Freedom® Standby Kit Shipping Container	2025-05-01