FDA.reportPublic FDA data

Promethean

Primary DI
B325PI44001
Brand
Promethean
Company
M D Technologies Inc.
Model
Island 4400
Catalog number
PI4400
Device description
Fluid Collecting Floor Mat for Collection, Measurement and Disposal of Surgical Fluids. Case of 8.
Published
2022-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLHWasher Of Body Waste Receptacles

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLHWasher Of Body Waste ReceptaclesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B325PI44001PrimaryHIBCC0
B325PI44000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobial, single-useA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8002013060sales@mdtechnologiesinc.com

Regulatory Flags#

DUNS number
859679045
Device count
8
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B325FM991Environ-mateFM99FM992022-08-05
B325PT20101Environ-matePT20-10PT20102022-08-05
B325PT20C101Environ-matePT20C-10PT20C102022-08-05
B325DM60001Environ-mateDM6000DM60002022-08-05
B325DM600021Environ-mateDM6000-2DM600022022-08-05
B325DM60002A1Environ-mateDM6000-2ADM60002A2022-08-05
B325DM6000FS1Environ-mateDM6000FSDM6000FS2022-08-05
B325FM990Environ-mateFM99FM992022-08-05
B325PI44000PrometheanIsland 4400PI44002022-08-05
B325PT20252Environ-matePT20-10PT20102022-08-05
B325PT20C100Environ-matePT20C-10PT20C102022-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520020636SteelcoSTEELCO SPAFLH2025-03-20
B325PI44000PrometheanM D Technologies Inc.FLH2022-08-05
05056097326191NinjoArjohuntleigh ABFLH2022-08-03
05056097335070TyphoonArjohuntleigh ABFLH2022-08-03
05056097335087NinjoArjohuntleigh ABFLH2022-08-03
05056097335117TornadoArjohuntleigh ABFLH2022-08-03
05056097336756TyphoonArjohuntleigh ABFLH2022-08-03
05056097336800TyphoonArjohuntleigh ABFLH2022-08-03
05056097340562TornadoArjohuntleigh ABFLH2022-08-03
05056097340579TornadoArjohuntleigh ABFLH2022-08-03
05056097340586NinjoArjohuntleigh ABFLH2022-08-03
05056097344331TornadoArjohuntleigh ABFLH2022-08-03
05056097356112TornadoArjohuntleigh ABFLH2022-08-03
05056097363479TornadoArjohuntleigh ABFLH2022-08-03
05056097370552TornadoArjohuntleigh ABFLH2022-08-03
05056341601913NinjoArjohuntleigh ABFLH2022-08-03
05056341698470NinjoArjohuntleigh ABFLH2022-08-03
08054188819123SteelcoSTEELCO SPAFLH2019-11-17
08058341872987SteelcoSTEELCO SPAFLH2019-11-17
08058341872994SteelcoSTEELCO SPAFLH2019-11-17
08058341873007SteelcoSTEELCO SPAFLH2019-11-17
08058341879740SteelcoSTEELCO SPAFLH2019-11-17
08058341879757SteelcoSTEELCO SPAFLH2019-11-17
07340153710306GETINGE 6000Getinge Disinfection ABFLH2017-07-04
07340153710313GETINGE 6000Getinge Disinfection ABFLH2017-07-04
07340153710320Getinge 600-SeriesGetinge Disinfection ABFLH2017-07-04
07340153710191GETINGE 1600-SERIESGetinge Disinfection ABFLH2017-04-12
07340153710207GETINGE 1800-SERIESGetinge Disinfection ABFLH2017-04-12
07340153710214GETINGE 1800-SERIESGetinge Disinfection ABFLH2017-04-12
07340153710221GETINGE 1800-SERIESGetinge Disinfection ABFLH2017-04-12