DEVICE: airNEST orange HYBRID (00670482000418)
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Device Identifier (DI) Information
airNEST orange HYBRID
USTAOHYBS-843507N-CT-BIL
In Commercial Distribution
Umano Medical Inc
USTAOHYBS-843507N-CT-BIL
In Commercial Distribution
Umano Medical Inc
Convertible air/foam Mattress System w. nylon cover 84"x35" and CT plate sleeve.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
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| No | |
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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? |
|---|---|---|---|---|
| 17593 | Low-air-loss bed |
A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
fb894de2-5696-4507-bf60-9660dc5218f9
April 30, 2021
1
April 22, 2021
April 30, 2021
1
April 22, 2021
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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