FDA.reportPublic FDA data

NP Duo™ Mattress

Primary DI
00845699008223
Brand
NP Duo™ Mattress
Company
SIZEWISE RENTALS, L.L.C.
Model
NP Duo
Device description
NP Duo Foam Mattress
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00845699008223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699008223008456990082238456990082230845699008223

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
967025602
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845699004942Mighty Rest Blower613550122026-05-08
00845699046430Agiliti - Essentia65-05-00002026-05-08
00845699046447Agiliti - Essentia65-05-00102026-05-08
00845699046454Agiliti - Capillaire CP-1020822026-05-08
00845699046461Agiliti - Capillaire CP-1018842026-05-08
00845699046478Agiliti - Capillaire CP-1023822026-05-08
00845699046485Agiliti - Capillaire CP-1023402026-05-08
00845699046492Agiliti - Capillaire CP-1020462026-05-08
00845699046515Agiliti - Capillaire CP-2033842026-05-08
00845699046522Agiliti - Capillaire CP-2026652026-05-08
00845699046539Agiliti - Capillaire CP-2026502026-05-08
00845699046546Agiliti - Capillaire 067-005-0102502026-05-08
00845699046386Agiliti HealthMedical Bed (FNL)2024-09-20
00845699008117Sizewise Manufacturing500601002024-09-20
00845699003525WOK4886-230V2024-09-13
00845699003730WOK5486-230V2024-09-13
00845699003747WOK6086-230V2024-09-13
00845699008124Sizewise Manufacturing500601502024-09-13
00845699004782Sizewise330605102024-08-30
00845699002238SizewiseBRP3 3948802024-08-06

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