FDA.reportPublic FDA data

Accessories

Primary DI
00810055882564
Brand
Accessories
Company
JOERNS HEALTHCARE, LLC
Model
N165
Catalog number
N165
Device description
ANGLE IND, HEAD SECT
Published
2022-04-05
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
OSIBariatric Bed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSIBariatric BedGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055882564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055882564008100558825648100558825640810055882564

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790937150
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00810055880126SlingsNA25705NA257052025-07-22
00810055884865Dolphin Fluid Immersion SimulationDLPH-3382OOEUJ-MDLPH-3382OOEUJ-M2025-07-10
00857268006707Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2025-07-10
00857268006851Dolphin Fluid Immersion SimulationDLPH-4882LPOOJ-MDLPH-4882LPOOJ-M2025-07-10
00857268006875Dolphin Fluid Immersion SimulationDLPH-3582OO4WJ-MDLPH-3582OO4WJ-M2025-07-10
00857268006752Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-CDLPH-1717WCOOJ-C2025-07-08
00857268006295Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-MDLPH-3582OOOOJ-M2025-07-07
00810055884834Panacea - DSPAN1000-FLEX-RILG2PAN1000-FLEX-RILG22025-06-18
00810055884841Panacea - DSPAN1K-FLEX-RILG2QSPAN1K-FLEX-RILG2QS2025-06-18
00810055884858Panacea - DSPAN1000-FLEX-RAHG2PAN1000-FLEX-RAHG22025-06-18
00857268006868Dolphin FISDLPP-2850CBJ-MDLPP-2850CBJ-M2025-05-29
00810055884407ProMatt PlusPMPE3480SZBAPMPE3480SZBA2025-05-08
00810055884384ProMatt PlusPMP3680SZBA-CPMP3680SZBA-C2025-04-24
00810055884391ProMatt PlusPMP4280SZBA-C2025-04-24
00810055884377ProMatt PlusPMPE3482SZBADTPMPE3482SZBADT2025-03-04
00810055884223Panacea 1000PAN1000-FLEX-RILQSPAN1000-FLEX-RILQS2024-11-20
00810055884216SlingsNA257052024-05-30
00810055884155Gel FoamPVEN-3576FLNA2SZP2024-03-25
00810055884162Gel FoamPVEN-3580FLNA2SZP2024-03-25
00810055884179Gel FoamPVEN-3584FLNA2SZP2024-03-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06979878770022CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770039CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770053CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770060CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770077CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
B303D040VersaTech 1100 ULBUsine Rotec IncOSI2025-04-11
B303D041VersaTech 1100 ULB+Usine Rotec IncOSI2025-04-11
B303D042VersaTech 1100 ULB+Usine Rotec IncOSI2025-04-11
10197344001750MEDLINEMEDLINE INDUSTRIES, INC.OSI2024-09-27
00817492013186NOA Medical Industries, LLCHoffmann NOA Medical Industries, LLCOSI2024-03-11
00817492013193NOA Medical Industries, LLCHoffmann NOA Medical Industries, LLCOSI2024-03-11
00841447108658Invacare(R) Bariatric Heavy Duty Full Electric Bed with Rails and Mattress KitINVACARE CORPORATIONOSI2023-12-18
00841447199946INVACARE® BARIATRIC TRAPEZEINVACARE CORPORATIONOSI2023-09-21
00817492013117Direct SupplyHoffmann NOA Medical Industries, LLCOSI2023-06-09
04050621100463sentida 6-xlWISSNER-BOSSERHOFF GmbHOSI2023-01-04
00810055882892AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
00810055882908AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
B303D0300VersaTech 1100 ULBUsine Rotec IncOSI2021-07-05
00815067071555PROBASICSCOMPASS HEALTH BRANDS CORP.OSI2020-09-07
00815067071562PROBASICSCOMPASS HEALTH BRANDS CORP.OSI2020-09-07
00815067071579PROBASICSCOMPASS HEALTH BRANDS CORP.OSI2020-09-07
00822383000442driveDrive Devilbiss HealthcareOSI2020-07-01
00822383551463driveDrive Devilbiss HealthcareOSI2020-07-01
00822383787398WenzeliteDrive Devilbiss HealthcareOSI2020-07-01
00822383935324driveDrive Devilbiss HealthcareOSI2020-07-01
00822383979441driveDrive Devilbiss HealthcareOSI2020-07-01
00822383979533driveDrive Devilbiss HealthcareOSI2020-07-01
00822383979540driveDrive Devilbiss HealthcareOSI2020-07-01
00822383255293DRIVEDrive Devilbiss HealthcareOSI2020-02-01