DEVICE: DynaRest Premium Visco-Gel Infused Foam Mattress (00616784042619)

Device Identifier (DI) Information

DynaRest Premium Visco-Gel Infused Foam Mattress
10426
In Commercial Distribution

Dynarex Corporation
00616784042619
GS1

1
008124539 *Terms of Use
DynaRest Premium Visco-Gel Infued Foam Mattress 80"x36"x6"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
60422 Gel-filled bed mattress
A large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IKY Mattress, Flotation Therapy, Non-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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

71ed4704-d21a-4548-9426-ddb02131f0e5
October 09, 2024
2
April 22, 2021
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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)

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

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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