AccessGUDID - DEVICE: SynCardia Companion Hospital Cart (00858000003138)

GUDID

Device Identifier (DI) Information

Brand Name: SynCardia Companion Hospital Cart
Version or Model: 397003-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYNCARDIA SYSTEMS, LLC

Primary DI Number: 00858000003138
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:	No
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	011
P030011	015
P030011	023

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 Temperature: between 4.5 and 40 Degrees Celsius
Storage Environment Temperature: between 4.5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 612672cc-f710-448d-bb6d-14df23d648ae
Public Version Date: May 01, 2025
Public Version Number: 1
DI Record Publish Date: April 23, 2025