AccessGUDID - DEVICE: SynCardia Companion 2 Driver (00858000003107)

GUDID

Device Identifier (DI) Information

Brand Name: SynCardia Companion 2 Driver
Version or Model: 397002-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYNCARDIA SYSTEMS, LLC

Primary DI Number: 00858000003107
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?
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	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 60 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 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 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c33b8bd-d326-41d5-826e-0000a3ad9faf
Public Version Date: March 13, 2025
Public Version Number: 4
DI Record Publish Date: October 23, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8667719437
Email: xx@xx.xx

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