DEVICE: NA (04037691242743)
Device Identifier (DI) Information
NA
Ven.Cath.,2-stage,reinf.,ell.,Light.tip
Not in Commercial Distribution
70100.5721
Maquet Cardiopulmonary AG
Ven.Cath.,2-stage,reinf.,ell.,Light.tip
Not in Commercial Distribution
70100.5721
Maquet Cardiopulmonary AG
Venous Catheter, two-stage, SLIM, complete reinforcement, elliptic proximal body, Lighthouse tip, with connector
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 |
DTL | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013944 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Outer Diameter 32/40 French |
Device Size Text, specify: Connection size 1/2 Inch |
Length: 40 Centimeter |
Device Record Status
e86dc676-21c4-4639-925a-65713bc9083c
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 |
---|---|---|---|---|---|
04037691362823 | 10 | 04037691242743 | 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