FDA.reportPublic FDA data

LUMEX

Primary DI
M3682100A2
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
2100A
Device description
Telescoping IV Pole
Published
2020-08-25
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

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3682100A2PackageHIBCC3In Commercial Distribution
M3682100A1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous poleA metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Commonly known as an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed or operating table, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels to allow patient mobility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
132016168
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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
00841027105695Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-06-26
00810050863483AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-06-08
00840117346307Vital Signs Stand, Compatible with item 10843Dynarex CorporationFOX2026-06-08
00761887005471PryorPRYOR PRODUCTSFOX2026-05-31
04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012409690Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012416728Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
04260217220158chapot® table System Siemens Artis zee / Q / Q.zenAmtrion GmbHFOX2026-03-30
04260217220196chapot® table System Siemens ARTIS pheno / iconoAmtrion GmbHFOX2026-03-30
09420012405999Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26