DEVICE: Isolibrium (07613327523867)

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Device Record History
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Device Identifier (DI) Information
Isolibrium
297300000000
In Commercial Distribution
297300000000
STRYKER CORPORATION
07613327523867
GS1

1
078470558 *Terms of Use
Isolibrium PE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
10348 Flotation therapy bed, adult
A mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IKZ BED, PATIENT ROTATION, POWERED
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6cf5a045-d26a-4529-9e4e-4b19822d449b
May 26, 2021
1
May 18, 2021
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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

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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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