FDA.reportPublic FDA data

oneNEST S

Primary DI
00670482001101
Brand
oneNEST S
Company
Umano Medical Inc
Model
303-804208HS4FB-BIL
Device description
oneNEST S 80''x 42'' is a non-powered foam surface
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10670482001108PackageGS11In Commercial Distribution
00670482001101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067048200110810670482001108
00670482001101006704820011016704820011010670482001101

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, 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. It may contain weight-distribution air cells. This is a reusable device.

Regulatory Flags#

DUNS number
249675476
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670482001118oneNEST S303-844208HS4FB-BIL2026-07-31
00670482001125oneNEST M303-M804208HS2FB-BIL2026-07-31
00670482001132oneNEST M303-M844208HS2FB-BIL2026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93352765Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
H93363822Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
00817012020229K-11KAP MEDICALIKY2026-08-21
00810055884414MATT 35X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884612MATT 42X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884636MATT 39X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884643MATT 42X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884674MATT 36X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884681MATT 42X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884704MATT 42X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884711MATT 35X84 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588472836X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16