DEVICE: Cool-Cap (00382830016308)

Device Identifier (DI) Information

Cool-Cap
60010-US
Not in Commercial Distribution
60010-US
NATUS MEDICAL INCORPORATED
00382830016308
GS1
September 15, 2014
1
962519208 *Terms of Use
OLYMPIC COOL CAP - US
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Circulating-fluid whole-body cooling system control unit A mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for cooling a patient’s whole-body (i.e., lower core body temperature). The device includes a refrigeration unit, a pump, and typically a fluid reservoir; it may also be intended for patient temperature monitoring. It is intended to be used by a healthcare professional in a clinical setting typically to treat patients who are hyperthermic/feverish or to induce hypothermia for metabolism reduction (e.g., during surgery).
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FDA Product Code

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Product Code Product Code Name
MXM Cap,Cooling (Infants)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P040025 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1420bb96-e049-469d-9b5b-caf52a9803b3
July 06, 2018
3
September 15, 2014
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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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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Yes
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Customer Contact

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No Customer Contact currently defined
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