DEVICE: QUADROX-i (04037691913032)

Device Identifier (DI) Information

QUADROX-i
Adult, reservoir, filter
In Commercial Distribution
70106.4568
Maquet Cardiopulmonary AG
04037691913032
GS1

1
316153865 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiotomy reservoir A device used to collect, store, and filter blood in an extracorporeal circuit during a cardiotomy procedure, typically a cardiopulmonary bypass procedure, trapping micro-particles and air bubbles for a period of time (e.g., 6 hours). It is typically a hardshell or soft, bag-like container with connectors and holds a reserve supply of blood for use in an extracorporeal circuit; some types may also defoam. It may also be used with other devices employed during short-term extracorporeal circulation or used postoperatively as a drainage and autotransfusion reservoir (e.g., for chest drainage) to return autologous blood shed for volume replacement. This is a sterile, single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DTP Defoamer, cardiopulmonary bypass
JOD FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS
DTN RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

0153d114-4357-492c-85c9-20952f27a79e
March 29, 2018
2
October 24, 2015
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49072229320
info.cp@maquet.com
CLOSE