FDA.reportPublic FDA data

oneNEST M Control unit

Primary DI
00670482000791
Brand
oneNEST M Control unit
Company
Umano Medical Inc
Model
303-MCU03NA115-BIL
Catalog number
303-MCU03NA115-BIL
Device description
The oneNEST M control unit (power cord 3 ft) is intended to be used with mattress oneNEST M. When connected to the mattress, it offers microclimate management with airflow
Published
2024-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOQBed, Flotation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10670482000798PackageGS11In Commercial Distribution
00670482000791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067048200079810670482000798
00670482000791006704820007916704820007910670482000791

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure inflatorAn electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The inflator, which may be referred to as a pump and may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.

Regulatory Flags#

DUNS number
249675476
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670482001019oneNEST M303-M803508HS2FB-BIL2026-04-24
00670482001026oneNEST M303-M843508HS2FB-BIL2026-04-24
00670482001071Echo-Flex 5002903-00002026-02-18
00670482000982Umano Connect282-0002282-00022025-08-04
00670482000920ook snowFL36 ook snowFL362025-05-16
00670482000944ook cocoonFL36 ook cocoonFL362025-05-16
00670482000951ook snow ALL200-0000200-00002025-05-16
10670482000927ook snowFL36 ook snowFL362025-05-16
00670482000937ook snow MHFL36 ook snow MHFL36 ook snow MH2025-05-16
10670482000941ook cocoonFL36 ook cocoonFL362025-05-16
10670482000958ook snow ALL200-0000200-00002025-05-16
00670482000463Freedom 500FM500FM5002021-02-05
00670482000487Freedom 1000FM1000FM10002021-06-04
00670482000470Freedom 1000FM1000FM10002021-02-05
00670482000838Patient Helper 299-0100WG-TRI299-0100WG-TRI2024-09-17
00670482000845REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64511-TRIFA64511-TRI2024-09-17
00670482000852REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64509-TRIFA64509-TRI2024-09-17
00670482000869REMOVABLE PATIENT CONTROL – 5 FUNCTIONS299-0152-TRI299-0152-TRI2024-09-17
00670482000876REMOVABLE PATIENT CONTROL – 5 FUNCTIONSFA64510-TRIFA64510-TRI2024-09-17
00670482000883REMOVABLE PATIENT CONTROL – 6 FUNCTIONS299-0151-TRI299-0151-TRI2024-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00670482001019oneNEST MUmano Medical IncIOQ2026-04-24
00670482001026oneNEST MUmano Medical IncIOQ2026-04-24
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