FDA.reportPublic FDA data

GENDRON

Primary DI
M368PL10001
Brand
GENDRON
Company
GF HEALTH PRODUCTS, INC.
Model
PL1000
Device description
PATIENT LIFT 1,000LB CAPACITY
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNGLift, Patient, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNGLift, Patient, Ac-PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368PL10001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mobile patient lifting system, electrically-poweredAn electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability 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). 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
7703684700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
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
06975960550565noneZhejiang Mateside Medical Devices Technology Co., LtdFNG2026-01-15
00860014621864ValmaxSupply Line MedicalFNG2025-12-22
06975960550558noneZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-09-29
06975960550510VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-06-04
06975960550527VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-05-19
06975960551395VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-04-30
00810178880522ViveVIVE HEALTH LLCFNG2025-04-04
00810178880706ViveVIVE HEALTH LLCFNG2025-04-04
10810178880529ViveVIVE HEALTH LLCFNG2025-04-04
10810178880703ViveVIVE HEALTH LLCFNG2025-04-04
06975960551357maidesiteZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-01-16
06977918410099AireMedJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-12-03
06977918410037SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410044SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410051SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410068SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410075SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410082SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
05060405748520GBUK LtdGBUK LTDFNG2024-11-08
05060405747554GBUK LtdGBUK LTDFNG2024-11-07
00860004936824EasyBoost 400Seneca Devices, Inc.FNG2024-10-17
00860004936831EasyBoostSeneca Devices, Inc.FNG2024-07-31
00860004936855EasyBoostSeneca Devices, Inc.FNG2024-07-09
05060405747837BananaGBUK LTDFNG2024-01-22
M368GT5XL1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368GT5XLC1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL1000S1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL7001GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL700S1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL8001GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04