DEVICE: SynCardia Hand Pump (00858000003114)
Device Identifier (DI) Information
SynCardia Hand Pump
397004-001
In Commercial Distribution
SYNCARDIA SYSTEMS, LLC
397004-001
In Commercial Distribution
SYNCARDIA SYSTEMS, LLC
No description.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 0 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
60cf18e3-0cbe-4079-b751-9a4d9e27cc52
March 13, 2025
4
October 23, 2015
March 13, 2025
4
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8667719437
XX@XX.XX
XX@XX.XX