FDA.reportPublic FDA data

Smart Rollboard

Primary DI
00628176153209
Brand
Smart Rollboard
Company
Samarit Medical Industries Inc
Model
5260
Device description
One Way Cushion
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628176153209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628176153209006281761532096281761532090628176153209

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Regulatory Flags#

DUNS number
247963056
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628176153001Smart Rollboard52482022-10-27
00628176153018Smart Rollboard41002022-10-27
00628176153025Smart Rollboard45002022-10-27
00628176153032Smart Rollboard44002022-10-27
00628176153049Smart Rollboard44602022-10-27
00628176153056Smart Rollboard44502022-10-27
00628176153063Smart Rollboard43002022-10-27
00628176153070Smart Rollboard43502022-10-27
00628176153087Smart Rollboard40102022-10-27
00628176153094Smart Rollboard40142022-10-27
00628176153100Smart Rollboard40882022-10-27
00628176153117Smart Rollboard40862022-10-27
00628176153124Smart Rollboard40872022-10-27

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10603354130514BAMEHOB INCFMR2024-09-03