DEVICE: CO-SET+ (07460691950023)
Device Identifier (DI) Information
CO-SET+
93611
Not in Commercial Distribution
93611
Edwards Lifesciences LLC
93611
Not in Commercial Distribution
93611
Edwards Lifesciences LLC
CO-SET+ (DUAL STOPCOCKS) CLOSED INJECTATE DELIVERY SYS
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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? |
---|---|---|---|---|
10615 | Thermal-dilution cardiac output unit |
A unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRB | PROBE, THERMODILUTION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K811399 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE. |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 10 Milliliter |
Device Record Status
b5e06c0f-815e-4342-bd56-d16b73960e6d
July 06, 2018
3
September 03, 2016
July 06, 2018
3
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 |
---|---|---|---|---|---|
57460691950028 | 10 | 07460691950023 | 2016-11-21 | Not in Commercial Distribution | Shipper |
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