FDA.reportPublic FDA data

STERISURE

Primary DI
B234KMHSS3100115V3
Brand
STERISURE
Company
CPAC EQUIPMENT, INC.
Model
3100
Device description
STATIC DRY HEAT STERILIZER
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KMHSterilizer, Dry Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMHSterilizer, Dry HeatGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B234KMHSS3100115V3PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dry-heat sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a heat source (e.g., electric heaters); and controls to regulate the time and/or temperature of the procedure. The heat may flow into the chamber either by natural convection or using forced air to accelerate and/or make more uniform the process (e.g., fans, high-speed hot air jets). The device is available in stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601985976
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B234FRGDHIS400635STERIDENT4006352018-09-20
B234KMHRHPRO111230V1RH-Pro11-230VRH-PRo11-230V2020-10-01
B234KMHRHPRO9115V3RH-Pro9RH-Pro92020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VRH-Pro9-230V2020-10-01
B234FRGSSNP400636STERIDENT4006362018-08-31
B234FRGSSNP400637STERIDENT4006372018-08-31
B234FRGSSNP400638STERIDENT4006382018-08-31
B234FRGSSNP400639STERIDENT4006392018-08-31
B234FRGSSNP400651STERIDENT4006512018-08-31
B234JCXPD101008115PORTODENT1010082018-08-31
B234JCXPD101009230PORTODENT1010092018-08-31
B234JCXPD101125115PORTODENT1011252018-08-31
B234KMHCX6000115V150COX RAPIDHEAT6000COX-115V-152018-07-31
B234KMHCX6000115V161COX RAPIDHEAT6000-16COX-115V-162018-08-23
B234KMHCX6220230V152COX RAPIDHEAT6220COX-230V-152018-08-24
B234KMHCX6220230V163COX RAPIDHEAT6220COX-230V-162018-08-24
B234KMHRHPRO111115V0RH-Pro11RH-Pro112019-01-18
B234KMHSD201000115STERIDENT2002018-08-31
B234KMHSD201000230STERIDENT2002018-08-31
B234KMHSD301000115STERIDENT3002018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B234KMHRHPRO111230V1RH-Pro11-230VCPAC EQUIPMENT, INC.KMH2020-10-01
B234KMHRHPRO9115V3RH-Pro9CPAC EQUIPMENT, INC.KMH2020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VCPAC EQUIPMENT, INC.KMH2020-10-01
M36883751GRAFCOGF HEALTH PRODUCTS, INC.KMH2020-08-24
M36883761GRAFCOGF HEALTH PRODUCTS, INC.KMH2020-08-24
B234KMHRHPRO111115V0RH-Pro11CPAC EQUIPMENT, INC.KMH2019-01-18
B234KMHSD201000115STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD201000230STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD301000115STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD301000230STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHCX6220230V152COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHCX6220230V163COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS2100115V2STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS2100230V0STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS3100230V1STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHCX6000115V161COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-23
B234KMHCX6000115V150COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-07-31
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