FDA.reportPublic FDA data

CONCERTO

Primary DI
05055982788106
Brand
CONCERTO
Company
Arjohuntleigh AB
Model
BAB2000-01
Catalog number
BAB2000-01
Device description
CONCERTO SHOWER TROLLEY, 1600MM HYDRAULIC
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055982788106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982788106050559827881065055982788106

GMDN Terms#

Term, Definition table
TermDefinition
Bathing/changing table, mobileA raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800) 323-1245us.info@arjo.com

Regulatory Flags#

DUNS number
355804758
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056097326191NinjoFG2B032HEUS12022-08-03
05056097335070TyphoonSA3H11B11AUS12022-08-03
05056097335087NinjoFG0C023LAUS02022-08-03
05056097335117TornadoFG6E043120AUS02022-08-03
05056097336756TyphoonSA3H11B11DUS12022-08-03
05056097336800TyphoonSA3H11B11BUS12022-08-03
05056097340562TornadoFA6E033120DUS12022-08-03
05056097340579TornadoFA7B031120DUS12022-08-03
05056097340586NinjoFA0B011LAUS12022-08-03
05056097344331TornadoFA7E031120DUS12022-08-03
05056097356112TornadoFA7E012010DUS12022-08-03
05056097363479TornadoFA3E031010AUS12022-08-03
05056097370552TornadoFA7E032021DUS12022-08-03
05056341601913NinjoFA1B021CAUS12022-08-03
05056341698470NinjoFA2C021CBUS02022-08-03
05055982763035Maxi MoveKMCEUN2022-07-29
05055982763042Maxi MoveKMCEUN-D2022-07-29
05055982763059Maxi MoveKMCEXN2022-07-29
05055982763325Maxi MoveKMCEXN-D2022-07-29
05055982764407Maxi MoveKMCLUN2022-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06975084500125CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500132CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500149CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500156CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500163CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
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06975084500194CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
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06975084500224CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500231CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500248CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500255CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500262CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500279CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500286CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023128CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-19
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10197344204540MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04
10197344204557MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04
10197344204564MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04