DEVICE: Anivia SG1000 Pump Console (00850000067097)
Device Identifier (DI) Information
Anivia SG1000 Pump Console
SG1000-PDM-004
In Commercial Distribution
SG1000-PDM-004
APMTD, Inc.
SG1000-PDM-004
In Commercial Distribution
SG1000-PDM-004
APMTD, Inc.
Pump Driver Module
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
33317 | Cardiopulmonary bypass system centrifugal pump drive unit |
A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWA | Control, Pump Speed, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K230698 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
93f90ad4-a323-4590-9b9e-06ad2bfd08b4
September 19, 2024
1
September 11, 2024
September 19, 2024
1
September 11, 2024
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
[?]
7816462900
support_anivia@aniviamed.com
support_anivia@aniviamed.com