FDA.reportPublic FDA data

Handicare

Primary DI
00810045514765
Brand
Handicare
Company
HANDICARE USA, INC.
Model
600032
Device description
Large Disposable Sling w/HS
Published
2020-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045516950PackageGS110In Commercial Distribution
00810045514765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045516950008100455169508100455169500810045516950
00810045514765008100455147658100455147650810045514765

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
800145836
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045517612Handicare520517340-12026-06-10
00810045517582Handicare5208A1200-S2025-08-13
00810045517599Handicare5208A1500-S2025-08-13
00810045517605Handicare5208A1600-S2025-08-13
00810045512785Handicare3030802020-12-14
00810045510040Handicare3030702020-07-02
00810045510385Handicare3030602020-07-02
00810045510392Handicare3030732020-07-02
00810045510408Handicare3030752020-07-02
00810045510415Handicare3030772020-07-02
00810045510422Handicare3030902020-07-02
00810045510439Handicare3030912020-07-02
00810045510446Handicare3030932020-07-02
00810045512808Handicare3030742020-07-02
00810045517575Handicare5204024552025-05-09
00810045517537Handicare520547050-102024-10-11
00810045517544Handicare520547060-102024-10-11
00810045517551Handicare520547070-102024-10-11
00810045517568Handicare520547080-102024-10-11
00810045517490Handicare520547050-102024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489003086MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-29
10888277658332MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-29
06972077023135CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023722CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023739CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023814CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077024033CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077025092CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500101CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500118CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500125CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500132CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500149CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500156CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500163CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500170CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500187CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500194CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500200CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500217CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500224CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500231CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500248CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500255CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500262CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500279CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500286CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023128CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-19
10688503002195M-SERIESSavaria Concord LiftFSA2026-09-18
10197344204540MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04