FDA.reportPublic FDA data

NA

Primary DI
07640141626146
Brand
NA
Company
Belimed AG
Model
MST-H
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
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640141626146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640141626146076401416261467640141626146

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume750Liter
Total Volume1010Liter
Total Volume1220Liter
Total Volume1435Liter

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
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
07640141626139NACS 7502016-06-28
07640141626153NAMST-V2016-06-28
07640141626177NAWD 290 IQNA2018-03-15

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07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
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06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
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06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
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05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
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