FDA.report

Handicare

Primary DI
00810045512136
Brand
Handicare
Company
HANDICARE USA, INC.
Model
400072
Device description
Medium Commode Sling
Published
2020-08-26
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
INESling, Overhead Suspension, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810045512136PrimaryGS10

GMDN Terms

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

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
false
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
00810045517513Handicare520547070-102024-10-11
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00810045517483Handicare520517505-12024-09-24
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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