FDA.reportPublic FDA data

CeroFrict

Primary DI
04897129990024
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML003-FJ09
Device description
Air Water Channel Cleaning Adapter
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897129990021PackageGS1150In Commercial Distribution
24897129990028PackageGS14In Commercial Distribution
04897129990024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999002114897129990021
2489712999002824897129990028
04897129990024048971299900244897129990024

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
687239367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
04897129990727CeroFrictSML005-BB032023-10-24
04897129990734CeroFrictSML005-BB042023-10-24
04897129990758CeroFrictSML005-BB052023-12-27
04897129990765CeroFrictSML005-BB062023-12-27
04897129990772CeroFrictSML011-PL022023-12-27
04897129990789CeroFrictSML004-PY062023-12-27
04897129990796CeroFrictSML004-PY072023-12-27
04897129990802CeroFrictSML004-PY082023-12-27
04897129990819CeroFrictSML004-PY092023-12-27
04897129990826CeroFrictSML004-PY102023-12-27
04897129990840CeroFrictSML007-TP032023-12-27
04897129990857CeroFrictSML007-TP042023-12-27
04897129990833CeroFrictSML004-PY112023-12-27
04897129990048CeroFrictSML004-PY022023-05-05
04897129990055CeroFrictSML004-PY032023-05-05
04897129990062CeroFrictSML004-PY042023-05-05
04897129990079CeroFrictSML004-PY052023-05-05
04897129990086CeroFrictSML005-BB012023-05-05
04897129990109CeroFrictSML007-TP012023-05-05
04897129990116CeroFrictSML011-PL012023-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603235041Disposable Cleaning BrushYangzhou Fartley Medical Instrument Technology Co., LtdMNL2026-10-22
06936603235072Disposable Cleaning BrushYangzhou Fartley Medical Instrument Technology Co., LtdMNL2026-10-22
06936603237373Disposable Cleaning BrushYangzhou Fartley Medical Instrument Technology Co., LtdMNL2026-10-22
00850025860970Endoscopy Kit - Basic Aux HBMicro-tech UsaMNL2026-10-12
04580826926044PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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04580826926471PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926488PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926648PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926679PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926686PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926761PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826927232PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928369PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928376PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931789PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931796PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931802PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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10810929045689Olympus Endoscopy KitRuhof CorporationMNL2026-08-07