AccessGUDID - DEVICE: SynCardia Freedom® Standby Kit Shipping Container (00858000003015)

GUDID

Device Identifier (DI) Information

Brand Name: SynCardia Freedom® Standby Kit Shipping Container
Version or Model: 295104-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYNCARDIA SYSTEMS, LLC

Primary DI Number: 00858000003015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080414145 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63640	Ventricular prosthesis system, pneumatically-powered	An assembly of devices intended to function as an artificial replacement for failing heart ventricles (end-stage biventricular failure), typically temporarily prior to heart transplantation. It consists of two implanted pneumatically-powered pumping units, with built-in mechanical heart valves, which replace the excised natural heart ventricles and are connected to the heart atria, aorta, and pulmonary arteries; the prosthesis is driven by an external pneumatic pump connected via percutaneous pneumatic drive-lines entering the patient's chest.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LOZ	Artificial Heart

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030011	020

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b5fc6a3-547f-4afa-a690-f4876558268b
Public Version Date: May 01, 2025
Public Version Number: 1
DI Record Publish Date: April 23, 2025