DEVICE: NA (04037691740348)
Device Identifier (DI) Information
NA
Venous Reservoir Bag 800 ml
Not in Commercial Distribution
70105.4265
Maquet Cardiopulmonary AG
Venous Reservoir Bag 800 ml
Not in Commercial Distribution
70105.4265
Maquet Cardiopulmonary AG
No description.
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. 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DTN | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090690 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: connector size outlet 3/8 Inch |
Total Volume: 800 Milliliter |
Device Size Text, specify: maximum blood flow6,5 [l/min] |
Pore Size: 185 Micrometer |
Device Size Text, specify: connector size cardiotomy outlet 3/8 Inch |
Device Size Text, specify: connector size venous inlet 1/2 Inch |
Device Record Status
aa732453-ae29-4fab-970a-15434830d339
February 03, 2020
6
October 24, 2015
February 03, 2020
6
October 24, 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 |
---|---|---|---|---|---|
04037691740331 | 10 | 04037691740348 | 2020-02-01 | Not in Commercial Distribution |
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
[?]
+49072229320
info.cp@maquet.com
info.cp@maquet.com