FDA.reportPublic FDA data

TITAN

Primary DI
G530TITAN10000
Brand
TITAN
Company
Nu Dimension Tech Ventures LLC
Model
1000
Catalog number
TITAN1000
Device description
Electrical Bariatric bed for healthcare (1000 LBS)
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G530TITAN10000PrimaryHIBCC0

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
131179203
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G530CZAPM360CZ-APM36CZ-APM-362023-11-06
G530CZAPM420CZ-APM42CZ-APM-422023-11-06
G530CZAPM480CZ-APM48CZ-APM-492023-11-06
G530CZAPMP360CZ-APM-P36CZ-APM-P-362023-11-06
G530CZAPMP420CZ-APM-P42CZ-APM-P-422023-11-06
G530CZAPMP480CZ-APM-P48CZ-APM-P-482023-11-06
G530PATLAL360PAT-LAL36PAT-LAL-36 2023-11-06
G530PATLAL420PAT-LAL42PAT-LAL-422023-11-06
G530PATLAL480PAT-LAL48PAT-LAL-482023-11-06
G530PATLALAP360PAT-ALA-AP36PAT-LAL-AP-36 2023-11-06
G530PATLALAP420PAT-ALA-AP42PAT-LAL-AP-42 2023-11-06
G530PATLALAP480PAT-ALA-AP48PAT-LAL-AP-48 2023-11-06
G530PATLRT360PAT-LRT36PAT-LRT-362023-11-06
G530PATLRT420PAT-LRT42PAT-LRT-422023-11-06
G530PATLRT480PAT-LRT48PAT-LRT-482023-11-06
G530TITAN3600E0TITAN3600ETITAN3600E2023-11-06
G530TITAN42000TITAN4200TITAN42002023-11-06
G530TITAN48000TITAN4800TITAN48002023-11-06
G530TITAN54000TITAN5400TITAN54002023-11-06
TITANLB600TITANLB6002023-10-02

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Primary DI, Brand, Company table
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