FDA.reportPublic FDA data

Steelco

Primary DI
08058341872994
Brand
Steelco
Company
STEELCO SPA
Model
BP 100 HSER
Catalog number
BP 100 HSER
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
2019-11-17
Public version status
Update
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
08058341872994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341872994080583418729948058341872994

GMDN Terms#

Term, Definition table
TermDefinition
Bedpan/ancillary utensil washer/disinfectorA mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and thermally disinfect (destroy microorganisms) reusable devices such as bedpans, urine bottles, suction bottles, emesis basins (Kidney bowls), hand wash basins, supports for single-use bedpans, flower vases and other similar reusable devices. The device is typically constructed with internal baskets/racks in the disinfecting chamber in/on which the medical devices are placed to ensure contact with all surfaces and parts. This device 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
08051520020636SteelcoBP 100 HSEBP 100 HSE2025-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520020636SteelcoSTEELCO SPAFLH2025-03-20
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
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