FDA.reportPublic FDA data

SARA PLUS

Primary DI
05055982799058
Brand
SARA PLUS
Company
Arjohuntleigh AB
Model
KKA5370-M
Device description
Sara Plus EPS Sling - M
Published
2022-08-30
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
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
05055982799058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982799058050559827990585055982799058

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient lifting system sling/harnessA general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.

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
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06975084500194CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
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06975084500231CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
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