FDA.reportPublic FDA data

CORIS Flushing Accessory

Primary DI
09350855000887
Brand
CORIS Flushing Accessory
Company
NANOSONICS LIMITED
Model
N05528
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
09350855001013Direct MarkingGS10
09350855000887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855001013093508550010139350855001013
09350855000887093508550008879350855000887

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000894CORIS Smart Seal AN055232026-05-20
09350855000900CORIS Smart Seal BN055242026-05-20
09350855000993CORIS Device BodyN055152026-05-20
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000146trophon Sonex-HLN05002N05002-12PK2018-06-15
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000573trophon Wireless Ultrasound Probe HolderN05030-USN05030-US2024-10-25
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21
09350855000122Trophon EPRN00010-US-RFB2016-09-21

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
09350855000894CORIS Smart Seal ANANOSONICS LIMITEDSEW2026-05-20
09350855000900CORIS Smart Seal BNANOSONICS LIMITEDSEW2026-05-20
09350855000993CORIS Device BodyNANOSONICS LIMITEDSEW2026-05-20