FDA.reportPublic FDA data

Steelco

Primary DI
08051520020636
Brand
Steelco
Company
STEELCO SPA
Model
BP 100 HSE
Catalog number
BP 100 HSE
Device description
This device is a multi-functional aid capable of holding all the receptacles commonly used in hospital, such as bedpans,urine bottle, suction bottle, bucket etc.With the use of a removable dedicated rack on slides, this device can be also for washing and disinfection (low intermediate) small objects.
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08051520020636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051520020636080515200206368051520020636

GMDN Terms#

Term, Definition table
TermDefinition
Bedpan/ancillary utensil washer-disinfector (thermal)An electrically-powered unit designed to both wash (remove organic debris, dirt, stains) and thermally disinfect (destroy microorganisms) reusable devices such as bedpans, urine bottles, suction bottles, emesis basins (kidney bowls), handwash basins and similar reusable devices. The device includes an internal chamber containing baskets/racks onto which the medical devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals, long-term care facilities, nursing homes and healthcare centres.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428717469
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051520024108SteelcoTW 3000/2TW 3000/22026-05-26
08051520022876SteelcoDS 1000 2SDS 1000 2S2026-04-17
08051520022852SteelcoDS 1000 2SDS 1000 2S2026-03-27
08051520022869SteelcoDS 1000 2SDS 1000 2S2026-02-04
08051520021176SteelcoDS 1000 2SDS 1000 2S2025-10-28
08051520021770SteelcoLC 80/3LC 80/32025-09-24
08051520021763SteelcoLC 80/2LC 80/22025-09-16
08051520011337SteelcoED 100/1ED 100/1 2025-07-24
08051520021473SteelcoTW 3000/2TW 3000/22025-07-24
08051520021480SteelcoLC 80/2LC 80/22025-07-24
08051520020957SteelcoDS 1000 2SDS 1000 2S2025-06-30
08051520021350SteelcoDS 1000 1SDS 1000 1S2025-06-18
08051520021145SteelcoID 300/1ID 300/12025-05-22
08051520021190SteelcoDS 1000 N1SDS 1000 N1S2025-05-22
08051520021169SteelcoDS 1000 2SDS 1000 2S2025-05-08
08051520020940SteelcoDS 1000 2SDS 1000 2S2025-05-05
08051520021022SteelcoAD 400/2AD 400/22025-04-22
08051520020797SteelcoDS 1000 NDS 1000 N2025-04-10
08051520020667SteelcoAD 400/2AD 400/22025-03-24
08051520019623SteelcoID 300/2ID 300/22025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B325PI44001PrometheanM D Technologies Inc.FLH2022-08-05
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