FDA.reportPublic FDA data

Promethean

Primary DI
B325PI44000
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002013060sales@mdtechnologiesinc.com

Regulatory Flags#

DUNS number
859679045
Device count
8
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
B325FM991Environ-mateFM99FM992022-08-05
B325PI44001PrometheanIsland 4400PI44002022-08-05
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
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
B325PI44001PrometheanM 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