DEVICE: SWAN-GANZ TRUE SIZE (00690103018295)
Device Identifier (DI) Information
SWAN-GANZ TRUE SIZE
TS105F5
In Commercial Distribution
TS105F5
Edwards Lifesciences LLC
TS105F5
In Commercial Distribution
TS105F5
Edwards Lifesciences LLC
SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F
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 |
DQE | CATHETER, OXIMETER, FIBEROPTIC |
KRA | Catheter, continuous flush |
DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
DQK | Computer, Diagnostic, Programmable |
DRS | Transducer, Blood-Pressure, Extravascular |
DSB | Plethysmograph, Impedance |
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
QAQ | Adjunctive Predictive Cardiovascular Indicator |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160084 | 000 |
K231248 | 000 |
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: 5F (1.67MM), USABLE LENGTH: 100 CM, RECOMMENDED GUIDEWIRE SIZE-DISTAL LUMEN: 0.018 IN, RECOMMENDED GUIDEWIRE SIZE-INJECTATE LUMEN: 0.020 IN, MINIMUM INTRODUCER SIZE: 5F (1.67 MM) |
Device Record Status
b838df7b-f909-4499-a07f-54c929db4768
May 20, 2025
7
September 03, 2016
May 20, 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