DEVICE: CO-SET+ (07460691949973)

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Device Identifier (DI) Information

CO-SET+
93505
93505
Edwards Lifesciences LLC
07460691949973
GS1
1
CO-SET HOUSING CASE OF 8
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
KRB PROBE, THERMODILUTION
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: SIZED FOR USE WITH THE EDWARDS CO-SET+ IN-LINE INJECTATE TEMPERATURE PROBE (MODEL 93522) AND ATTACHMENT TO THE CATHETER INJECTATE LUMEN STOPCOCK.
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Device Status

In Commercial Distribution
September 03, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
57460691949978 8 07460691949973 In Commercial Distribution Shipper
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
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