FDA.reportPublic FDA data

Handicare

Primary DI
00810045514314
Brand
Handicare
Company
HANDICARE USA, INC.
Model
537650
Device description
BC Hygiene-Qltd-XXL Buckle
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810045514314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045514314008100455143148100455143140810045514314

GMDN Terms#

Term, Definition table
TermDefinition
Patient lifting system hammock slingA 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 or semi-recumbent position with their body (back, head, arms, buttocks and upper legs) enveloped within the sling. It is typically designed as a rectangular piece of strengthened fabric with lifting straps or eyes; it may be with or without a commode aperture. This type of sling disperses the body weight over a large area of material reducing the likelihood of pressure sores; no user cooperation is required. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800145836
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810045517506Handicare520547060-102024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10688503001877M-SERIESSavaria Concord LiftFSA2026-04-24
10688503001884M-SERIESSavaria Concord LiftFSA2026-04-24
10884389177624MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10884389196854MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10197344036653MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-03-04
10197344170067MEDLINEMEDLINE INDUSTRIES, INC.FSA2025-11-07
10688503001662M-SERIESSavaria Concord LiftFSA2025-10-31
10688503001655M-SERIESSavaria Concord LiftFSA2025-10-30
10688503001624M-SERIESSavaria Concord LiftFSA2025-10-21
10688503001631M-SERIESSavaria Concord LiftFSA2025-10-21
10688503001648M-SERIESSavaria Concord LiftFSA2025-10-21
10688503001617M-SERIESSavaria Concord LiftFSA2025-10-20
10688503001594M-SERIESSavaria Concord LiftFSA2025-10-09
00816299012606HoverMatt PROS Hovertech InternationalFSA2025-09-10
00816299012613HoverMatt PROS Hovertech InternationalFSA2025-09-10
00816299012798HoverMatt PROS Hovertech InternationalFSA2025-09-10
10197344130245MEDLINEMEDLINE INDUSTRIES, INC.FSA2025-01-03
10197344129980MEDLINEMEDLINE INDUSTRIES, INC.FSA2024-12-19
10197344130078MEDLINEMEDLINE INDUSTRIES, INC.FSA2024-12-19
10884389120682MEDLINEMEDLINE INDUSTRIES, INC.FSA2024-12-10
00810045517537HandicareHANDICARE USA, INC.INE2024-10-11
00810045517544HandicareHANDICARE USA, INC.INE2024-10-11
00810045517551HandicareHANDICARE USA, INC.INE2024-10-11
00810045517568HandicareHANDICARE USA, INC.INE2024-10-11
10603354130323BAMEHOB INCFSA2024-09-03
10603354130347BAMEHOB INCFSA2024-09-03
10603354130361BAMEHOB INCFSA2024-09-03
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFSA2024-03-26
07613327632880Sage TAP LCSAGE PRODUCTS, LLCFSA2024-03-26
10888277700147MedlineMEDLINE INDUSTRIES, INC.FSA2023-12-26