FDA.reportPublic FDA data

CORIS Adaptor Reprocessing Hub

Primary DI
09350855001068
Brand
CORIS Adaptor Reprocessing Hub
Company
NANOSONICS LIMITED
Model
N05539
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SEWAutomated Endoscope Channel Cleaner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEWAutomated Endoscope Channel CleanerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855001051Direct MarkingGS10
09350855001068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855001051093508550010519350855001051
09350855001068093508550010689350855001068

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope flushing/rinsing sink systemAn electrically-powered assembly of devices intended to be used to flush and rinse endoscopes for pre-cleaning. It is intended to be connected to hot and cold water supplies and includes a sink with conventional style taps to facilitate pre-cleaning the external portion of the endoscopes, and a series of fluid lines for flushing each endoscope channel.

Regulatory Flags#

DUNS number
741021943
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21
09350855000023Sonex-HLN000372016-09-21
09350855000030Sonex-HLN00037-NNA2016-09-21
09350855000122Trophon EPRN00010-US-RFB2016-09-21
09350855000559trophon Curved Probe PositionerN00099N000992022-07-08
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000184trophon2N05000-12018-06-15
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000887CORIS Flushing AccessoryN055282026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09350855000580CORIS QUANTUM Cleaning AgentNANOSONICS LIMITEDSEW2026-05-20
09350855000818CORIS Device EngineNANOSONICS LIMITEDSEW2026-05-20
09350855000832CORIS Adaptor O1NANOSONICS LIMITEDSEW2026-05-20
09350855000849CORIS Smart Drain Adaptor OANANOSONICS LIMITEDSEW2026-05-20
09350855000856CORIS Smart DrainNANOSONICS LIMITEDSEW2026-05-20
09350855000863CORIS Maintenance KitNANOSONICS LIMITEDSEW2026-05-20
09350855000887CORIS Flushing AccessoryNANOSONICS LIMITEDSEW2026-05-20
09350855000894CORIS Smart Seal ANANOSONICS LIMITEDSEW2026-05-20
09350855000900CORIS Smart Seal BNANOSONICS LIMITEDSEW2026-05-20
09350855000993CORIS Device BodyNANOSONICS LIMITEDSEW2026-05-20