DEVICE: Quattro, Japan, Final Packaged Kit (Applause) (00849111050050)

Device Identifier (DI) Information

Quattro, Japan, Final Packaged Kit (Applause)
IC-4593
In Commercial Distribution

Zoll Circulation, Inc.
00849111050050
GS1

1
799455241 *Terms of Use
No description.
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Device Characteristics

MR Safe
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?
44708 Intravascular core temperature regulation system catheter
A flexible tube with an attached membrane (e.g., a balloon) intended to be inserted into the central venous system (CVS) to circulate through the membrane a temperature-controlled fluid (e.g., saline solution), in order to both heat and alternatively cool a patient's blood through the transfer of heat across the membrane. It may have built-in sensors to monitor the patient's body temperature for feedback to a connected control unit. It may be used for body temperature regulation during surgery, intensive care, or for fever management. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NCX System, Hypothermia, Intravenous, Cooling
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K101987 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 45 Centimeter
Catheter Gauge: 9.3 French
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Device Record Status

a060d6c5-3011-4635-9f53-8167388e92e6
December 18, 2023
4
October 10, 2016
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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

[?]
4085412140
udisj@zoll.com
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