DEVICE: NA (04037691241814)
Device Identifier (DI) Information
NA
Ven.Cath.,reinf.,Pilot tip,straight
Not in Commercial Distribution
70100.4595
Maquet Cardiopulmonary AG
Ven.Cath.,reinf.,Pilot tip,straight
Not in Commercial Distribution
70100.4595
Maquet Cardiopulmonary AG
Venous Catheter, wire reinforced, Pilot tip, straight
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? |
---|---|---|---|---|
34905 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous |
A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020784 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Connection size 3/8 Inch |
Catheter Gauge: 20 French |
Length: 33 Centimeter |
Device Record Status
db0c60ae-36a5-49a6-a385-4bfb1caf98ad
August 05, 2022
6
October 24, 2015
August 05, 2022
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 |
---|---|---|---|---|---|
04037691409665 | 10 | 04037691241814 | 2020-01-31 | 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