FDA.reportPublic FDA data

NA

Primary DI
07640141626139
Brand
NA
Company
Belimed AG
Model
CS 750
Published
2016-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07640141626139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640141626139076401416261397640141626139

GMDN Terms#

Term, Definition table
TermDefinition
Surgical utensil washer/disinfectorA mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most instruments, especially those used invasively or in a sterile field will require sterilization after this process. It is typically located in rooms and central supply departments designed to handle soiled instruments/utensils. It typically includes internal baskets/racks in which the utensils are placed to ensure circulation of the heated water/detergents to all surfaces.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2700Liter
Total Volume4600Liter
Total Volume5900Liter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8432167424sean.colwell@belimed.com
8432167424andreja.tajnic@belimed.com
8436074608steven.sutton@belimed.com

Regulatory Flags#

DUNS number
480030261
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
07640141626023NAWD 2002016-06-28
07640141626047NAWD 2502016-06-28
07640141626054NAWD 2902016-06-28
07640141626078NAWD 3902016-06-28
07640141626122NAWD 7502016-06-28
07640141626146NAMST-H2016-06-28
07640141626153NAMST-V2016-06-28
07640141626177NAWD 290 IQNA2018-03-15

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
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