FDA.report

Handicare

Primary DI
00810045512488
Brand
Handicare
Company
HANDICARE USA, INC.
Model
450001
Device description
Low Profile Lift
Published
2020-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810045512488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045512488008100455124888100455124880810045512488

GMDN Terms

TermDefinition
Mobile patient lifting system, battery-poweredA battery-powered, mobile 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. 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), and a rechargeable battery. 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

Regulatory Flags

DUNS number
800145836
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

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00810045517490Handicare520547050-102024-10-11
00810045517506Handicare520547060-102024-10-11
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00810045513553Handicare5208E4432-S-12020-11-16
00810045513836Handicare520280070-B-12020-11-16
00810045517476Handicare3609802024-05-10
00810045517445Handicare520537610-12023-10-26
00810045517421Handicare520547060-22023-10-23
00810045517438Handicare520547070-22023-10-23
00810045512761Handicare520517520-12023-07-11
00810045512754Handicare520547070-12023-05-01
00810045512693Handicare520580500-B2022-12-07
00810045512730Handicare5208A1300-S2022-12-07
00810045513072Handicare5208A1400-S2022-12-07

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