DEVICE: CoolAdvantage Petite Card (00081641702102)

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Device Identifier (DI) Information

CoolAdvantage Petite Card
BRZ-CD4-140-003
BRZ-CD4-140-003
Zeltiq Aesthetics, Inc.
00081641702102
GS1
1
CoolAdvantage Petite Card, CD4, Direct, 3 Cycles
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Cryolipolysis body contouring system program card A portable electronic device designed to connect to the data port of a cryolipolysis body contouring system to provide its control unit with a selected treatment profile. It contains data such as cooling intensity factor (CIF), cycle time and other relevant treatment data, and is factory programmed so that the data cannot be modified. It is made of metal and plastic materials and has a connector at one end to connect to computerized devices. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
OOK Dermal Cooling Pack/Vacuum/Massager
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 31, 2017

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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
888-935-8471
support@zeltiq.com
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