FDA.reportPublic FDA data

SARA COMBILIZER

Primary DI
05055982788571
Brand
SARA COMBILIZER
Company
Arjohuntleigh AB
Model
APA1000-US
Device description
SARA COMBILIZER - Early mobilisation moveable chair/table - powered
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055982788571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982788571050559827885715055982788571

GMDN Terms#

Term, Definition table
TermDefinition
Mobile patient lifting system, electrically-poweredAn electrically-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 motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05059441537298AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
05059441537304AIRPALAP-034SPNB AP-034SPNB 2026-03-23
05059441537311AIRPALAP-034SPNBSHAP-034SPNBSH2026-03-23
05059441537328AIRPALAP-039SPNB AP-039SPNB 2026-03-23
05059441537335AIRPALAP-039SPNBSH AP-039SPNBSH2026-03-23
05059441537342AIRPALAP-050SPNB AP-050SPNB 2026-03-23
05059441380450Arjo Loop Ambulatory SlingMLA5100-SMLA5100-S2026-03-09
05059441380467Arjo Loop Ambulatory SlingMLA5100-MMLA5100-M2026-03-09
05059441380474Arjo Loop Ambulatory SlingMLA5100-LMLA5100-L2026-03-09
05059441380481Arjo Loop Ambulatory SlingMLA5100-XLMLA5100-XL2026-03-09
05059441461654TherarestTRMRLNB35579TEGTRMRLNB35579TEG2026-02-10
05056097349510SARA FLEXTSS.500WTSS.500W2022-09-03
05056097364049SARA FLEXTSS.503WTSS.503W2022-09-03
05056097369921SARA FLEXTSS.501WTSS.501W2022-09-03
05056097369938SARA FLEXTSS.502WTSS.502W2022-09-03
05059441536024AtmosAir Velaris633042US633042US2026-01-15
05059441536031AtmosAir Velaris633043US633043US2026-01-15
05059441536048AtmosAir Velaris633044US633044US2026-01-15
05059441536055AtmosAir Velaris633045US633045US2026-01-15
05059441536062AtmosAir Velaris633046US633046US2026-01-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00815235022136UMF MEDICALUNITED METAL FABRICATORS, INC.INQ2025-04-08
00815235022143UMF MEDICALUNITED METAL FABRICATORS, INC.INQ2025-04-08
00815235022150UMF MEDICALUNITED METAL FABRICATORS, INC.INQ2025-04-08
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00815235022174UMF MEDICALUNITED METAL FABRICATORS, INC.INQ2025-04-08
00815235022181UMF MEDICALUNITED METAL FABRICATORS, INC.INQ2025-04-08
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