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

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055883028JOERNS HOY UP STANDAID, 440LBSHOY-UP2026-08-15
00810055884414MATT 35X80 DELUXE STR ZIP COV CAPDF3580SZ500CA2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CPEGF3580SZ500CA2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAPEGF3580SZP500CA2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAPDF3576SZ500CA2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAPDF4280SZ500CA2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CPEGF4280SZ500CA2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAPDS3580SZ500CA2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CPEGS3580SZ500CA2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAPBF3580SZ500CA2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CPEGF3576SZ500CA2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAPDF3584SZ500CA2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAPEGF3584SZP500CA2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CPEGF4280SZ600CA2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAPDS3576SZ500CA2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAPDF3680SZ500CA2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CPEGF3680SZ500CA2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CPEGF3580SZ600CA2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CPEGS3576SZ500CA2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CPEGF3584SZ500CA2026-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161720056VersaTech Bariatric 1100 ULB+ Usine Rotec IncOSI2026-04-28
07540161720063VersaTech Bariatric 1100 ULB+ Usine Rotec IncOSI2026-04-28
07540161720070VersaTech Bariatric 1100 ULB+ Usine Rotec IncOSI2026-04-28
06979878770015CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
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
04050621100555sentida 5 xxlWISSNER-BOSSERHOFF GmbHOSI2024-08-29
04050621100609sentida sc-xl USAWISSNER-BOSSERHOFF GmbHOSI2024-08-29
04050621100616sentida sc-xxl USAWISSNER-BOSSERHOFF GmbHOSI2024-08-29
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
00817492013100Direct SupplyHoffmann NOA Medical Industries, LLCOSI2023-01-06
04050621100463sentida 6-xlWISSNER-BOSSERHOFF GmbHOSI2023-01-04
04050621100456sentida 5-xlWISSNER-BOSSERHOFF GmbHOSI2022-10-28
00810055882892AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
00810055882908AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
B303D0300VersaTech 1100 ULBUsine Rotec IncOSI2021-07-05
10888277651838MedlineMEDLINE INDUSTRIES, INC.OSI2020-11-03
00815067071555PROBASICSDrive Devilbiss HealthcareOSI2020-09-07
00815067071562PROBASICSDrive Devilbiss HealthcareOSI2020-09-07