FDA.reportPublic FDA data

SARA STEDY

Primary DI
05056097341286
Brand
SARA STEDY
Company
Arjohuntleigh AB
Model
NTB3000
Device description
SARA STEDY COMPACT - Standing and raising aid
Published
2022-07-27
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
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056097341286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056097341286050560973412865056097341286

GMDN Terms#

Term, Definition table
TermDefinition
Mobile patient lifting system, manualA non-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a lifting mechanism, mast, boom, swivel bar, and patient holding device (e.g., a sling, holder or a frame). The lifting mechanism provides mechanical advantage (e.g., using pneumatic springs) to aid manual movement of components. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.

Sterilization Methods#

Method table
Method

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
Primary DIBrandCompanyProduct codePublished
08054040400612ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400629ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400636ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400643ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400650ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400667ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402074ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402081ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402098ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402104ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402111ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402128ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402210ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402227ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402234ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402241ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402258ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402265ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402272ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402289ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402296ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402302ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402319ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402326ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402333ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402340ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402357ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402364ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402371ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402388ADJUSTABLE TROLLIORMESA SRLINM2026-09-06