DEVICE: Cool Point™ (05415067008985)

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Device Identifier (DI) Information

Cool Point™
IBI-89003
IBI-89003
IRVINE BIOMEDICAL, INC.
05415067008985
GS1
1
Irrigation Pump
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Device Characteristics

MR Unsafe
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
Cardiac ablation system irrigation tubing set A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -20 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 29, 2014

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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
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Secondary DI

[?]
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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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