FDA.reportPublic FDA data

LUMEX

Primary DI
M368UPH8641
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
UPH864
Catalog number
UPH864
Device description
SLNG UNIV FULL HEAD SUPPT 600#
Published
2021-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368UPH8641PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient lifting system sling/harnessA general-purpose 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 position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@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
10688503001938M-SERIESSavaria Concord LiftFSA2026-06-22
05600494139948Invacare Birdie Evo XPlus Full Body LiftINVACARE CORPORATIONFSA2026-06-03
05404016613813Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613820Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613837Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613844Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613851Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613868Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613875Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613882Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613899Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613905Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613912Handi-Move SpreaderbarHandi-MoveFSA2026-06-02
05404016613929Handi-Move SpreaderbarHandi-MoveFSA2026-06-02
05404016613936Handi-Move SpreaderbarHandi-MoveFSA2026-06-02
05404016613943Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613950Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613967Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613974Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613981Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613998Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614001Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614018Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614025Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614032Handi-Move SlingHandi-MoveFSA2026-06-02
10688503001877M-SERIESSavaria Concord LiftFSA2026-04-24
10688503001884M-SERIESSavaria Concord LiftFSA2026-04-24
10884389177624MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10884389196854MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10688503001860M-SERIESSavaria Concord LiftFSA2026-03-19