LUMEX

Primary DI
M3685597R5411
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
5597R-54-1
Catalog number
5597R-54-1
Device description
"54"" Gait Belt"
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQBBelt, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQBBelt, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3685597R5412PackageHIBCC50In Commercial Distribution
M3685597R5411PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair/stander occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.

Contacts#

Phone, Email table
PhoneEmail
7703684700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330702574ProCureTwin Med, LLCIQB2026-05-06
10840330702581ProCureTwin Med, LLCIQB2026-05-06
10840330702598ProCureTwin Med, LLCIQB2026-05-06
10840330702604ProCureTwin Med, LLCIQB2026-05-06
10860014621885ValmaxSupply Line MedicalIQB2025-11-04
00841447115809Freedom Designs™ Hip Belt with Squeeze Side Release Plastic BuckleINVACARE CORPORATIONIQB2025-10-27
00841447115816Freedom Designs™ Hip Belt with Push Button BuckleINVACARE CORPORATIONIQB2025-10-27
00841447115823Freedom Designs™ Hip Belt with Airline Style BuckleINVACARE CORPORATIONIQB2025-10-27
00841447115830Freedom Designs™ 4-Point Hip BeltINVACARE CORPORATIONIQB2025-10-27
00841447115847Freedom Designs™ Hip Belt GuidesINVACARE CORPORATIONIQB2025-10-27
00841447114901ASM, STRAP POSITIONING BUCKLE BUTTONINVACARE CORPORATIONIQB2024-07-25
00841447114918POS STRAP 23-24W HOOK/LOOPINVACARE CORPORATIONIQB2024-07-25
00041298501367DMID-M-S HOLDINGS, INC.IQB2023-07-11
10041298501364DMID-M-S HOLDINGS, INC.IQB2023-07-11
07540147002992Push-Button Style Pelvic Lap BeltMotion Concepts IncIQB2023-06-22
00733657197761ALIMED BLUE SEATBELT 3/PKALIMED, INC.IQB2022-12-01
00733657229509EZ RELEASE SEATBELT EXTENDERALIMED, INC.IQB2022-12-01
20885632061629MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-14
20885632061643MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-14
10885632061622MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-14
10885632061646MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-14
50885632110793MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
50885632110809MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
50885632110816MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
50885632110823MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
50885632110830MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
50885632110847MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
10885632110795MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
10885632110801MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13
10885632110818MediChoiceOWENS & MINOR DISTRIBUTION, INC.IQB2020-10-13