DEVICE: LUMEX (M368LS900481)

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Device Record History
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Device Identifier (DI) Information
LUMEX
LS900-48
In Commercial Distribution

GF HEALTH PRODUCTS, INC.
M368LS900481
HIBCC

1
132016168 *Terms of Use
Lumex Select AeroComfort AP LAL 48x80 System
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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
IOQ Bed, Flotation Therapy, 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 Temperature: between -25 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ab44e0af-c0dc-4a41-9227-b363c5088ba5
March 10, 2025
1
March 01, 2025
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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

[?]
770-368-4700
cs@grahamfield.com
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