DEVICE: Adult Custom Pack (00607567202993)
Device Identifier (DI) Information
Adult Custom Pack
BEQ-TOP- 32100
Not in Commercial Distribution
701054438
DATASCOPE CORP.
BEQ-TOP- 32100
Not in Commercial Distribution
701054438
DATASCOPE CORP.
701053325 BEQ-HMOD 70000-USA Adult Quadrox iD
701020489 BEQ-RF32 RotaFlow
701045763 Gas Filter
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
36347 | Cardiopulmonary bypass system roller pump |
A mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWE | Tubing, Pump, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
605e27fd-1798-44d3-9dd5-6fd9f64de23c
December 05, 2018
3
October 26, 2015
December 05, 2018
3
October 26, 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
[?]
18886278383
cpsurgery@maquet.com
cpsurgery@maquet.com