DEVICE: SWAN-GANZ CCOMBO V (00690103146554)
Device Identifier (DI) Information
SWAN-GANZ CCOMBO V
777F8
In Commercial Distribution
777F8
Edwards Lifesciences LLC
777F8
In Commercial Distribution
777F8
Edwards Lifesciences LLC
SWAN-GANZ CCOMBO V THERMODILUTION CATHETER
Device Characteristics
MR Unsafe | |
Yes | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
34925 | Pulmonary artery balloon catheter, electrical |
A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYG | CATHETER, FLOW DIRECTED |
KRA | Catheter, continuous flush |
DQE | CATHETER, OXIMETER, FIBEROPTIC |
DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Exterior Diameter: 7.5F (2.5mm), Usable Length: 110cm, Recommended Guidewire Size: 0.018 in (0.46 mm), Minimum Introducer Size: 9F (3.0mm) |
Device Record Status
57392d1f-3d0d-439b-ae88-17e4118b4c65
June 09, 2025
7
September 03, 2016
June 09, 2025
7
September 03, 2016
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 |
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
[?]
+1(800)822-9637
tech_support@edwards.com
tech_support@edwards.com