DEVICE: Sustainable Technologies (10885380203206)
Device Identifier (DI) Information
Sustainable Technologies
RGMT34HLF-REG-B
In Commercial Distribution
RGMT34HLF-REG-B
Cardinal Health 200, LLC
RGMT34HLF-REG-B
In Commercial Distribution
RGMT34HLF-REG-B
Cardinal Health 200, LLC
Regard HoverMatt® SPU Air Transfer Mattress
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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66401 | Inflatable patient transfer sliding mattress, reprocessed |
An inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques. It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FRZ | DEVICE, PATIENT TRANSFER, POWERED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ee7c78b6-2650-4f43-8166-8e68be2c6b27
January 29, 2025
1
January 21, 2025
January 29, 2025
1
January 21, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined