DEVICE: Cool Point™ (05414734258616)

Device Identifier (DI) Information

Cool Point™
85785
In Commercial Distribution
85785
IRVINE BIOMEDICAL, INC.
05414734258616
GS1

1
926346966 *Terms of Use
Tubing Set
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
44772 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.
Active false
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P060019 005
P060019 056
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2354965d-9f38-42fd-b5e5-f43927c91930
June 14, 2024
4
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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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