DEVICE: QUADROX-i (04037692010006)

Device Identifier (DI) Information

QUADROX-i
Small Adult, reservoir
Not in Commercial Distribution
70106.7967
Maquet Cardiopulmonary AG
04037692010006
GS1
February 15, 2017
1
316153865 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
31710 Cardiotomy reservoir
A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.
Active false
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K132166 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

542e59a7-f340-45f2-bd26-6a5100d39118
January 22, 2020
4
December 15, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04037692011362 2 04037692010006 2017-02-15 Not in Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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