FDA.reportPublic FDA data

MEDACURE

Primary DI
00853223008014
Brand
MEDACURE
Company
MEDACURE INC.
Model
FS660
Device description
FREE SPIRIT
Published
2019-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNGLift, Patient, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNGLift, Patient, Ac-PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853223008014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853223008014008532230080148532230080140853223008014

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient lifting system, line-poweredA mains electricity (AC-powered), stationary assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability, of any size and weight, safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist, it typically consists of a support base (non-fixed and freestanding on the floor) with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, and patient holding device (e.g., a sling, holder or a frame). Repositioning of the assembly may be achieved by lifting it to a new position/location.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079352467
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
00853223008397MEDACURECB6502020-10-01
00853223008403MEDACURECB10002020-10-01
00853223008359MEDACUREWC26202020-10-02
00853223008366MEDACUREWC28202020-10-02
00853223008373MEDACUREWC30202020-10-02
00853223008380MEDACUREGC5002020-10-01
00853223008410MEDACURERB5002020-10-01
00853223008342MEDACUREOS200-C2019-10-25
00853223008328MEDACUREULB7/302019-10-04
00853223008335MEDACUREULB48-X-7/302019-10-04
00853223008304MEDACUREPNP362019-09-27
00853223008311MEDACUREPNP36-RR2019-09-27
00853223008298MEDACUREBP3002019-09-12
00853223008021MEDACUREAL182019-08-16
00853223008038MEDACUREAL202019-08-16
00853223008045MEDACUREAL222019-08-16
00853223008052MEDACUREAL242019-08-16
00853223008007MEDACURELRM362019-02-15
00853223008069MEDACUREULB3.92019-02-15
00853223008076MEDACUREAS362019-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06975960550527VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-05-19
06975960551395VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-04-30
00810178880522ViveVIVE HEALTH LLCFNG2025-04-04
00810178880706ViveVIVE HEALTH LLCFNG2025-04-04
10810178880529ViveVIVE HEALTH LLCFNG2025-04-04
10810178880703ViveVIVE HEALTH LLCFNG2025-04-04
06975960551357maidesiteZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-01-16
06977918410099AireMedJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-12-03
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06977918410082SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
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05060405747837BananaGBUK LTDFNG2024-01-22
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M368PL1000S1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
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M368PL700S1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04