DEVICE: SKIN IQ 365 (05055982783248)

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Device Identifier (DI) Information

SKIN IQ 365
SIQPSRU04UN

Arjohuntleigh AB
05055982783248
GS1
1
SKIN IQ 365, POWER SUPPLY - 4 UNITS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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
Circulating-air whole-body heating/cooling system control unit A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating/cooling system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating and alternatively cooling a patient’s whole-body (i.e., elevate or lower core body temperature). The device includes a filter, an air heating and cooling mechanism and air pump. It is intended to be used by a healthcare professional in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
IOQ BED, FLOTATION THERAPY, POWERED
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Sterilization

No
No
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 Status

In Commercial Distribution
September 29, 2016

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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
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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