AccessGUDID - DEVICE: SynCardia Companion Rechargeable LI-ION Battery (00858000003077)

GUDID

Device Identifier (DI) Information

Brand Name: SynCardia Companion Rechargeable LI-ION Battery
Version or Model: 293001-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYNCARDIA SYSTEMS, LLC

Primary DI Number: 00858000003077
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:	Yes
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?
16977	Artificial heart, temporary	A sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly as a bridge to heart transplantation.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LOZ	Artificial Heart

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030011	011
P030011	013
P030011	015
P030011	022
P030011	023
P030011	027

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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 697 and 1090 millibar
Handling Environment Temperature: between 0 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 697 and 1090 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4833bf15-9588-4d93-a18f-acd1a0476c5c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 23, 2015