FDA.reportPublic FDA data

CeroFrict

Primary DI
04897129990000
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML001-PT12
Device description
Air Water Channel Cleaning Adapter
Published
2023-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
14897129990007PackageGS1150In Commercial Distribution
24897129990004PackageGS14In Commercial Distribution
04897129990000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999000714897129990007
2489712999000424897129990004
04897129990000048971299900004897129990000

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897129990550CeroFrictSML002-LP012023-04-17
04897129990642CeroFrictSML003-FJ012023-04-17
04897129991342CeroFrictSML011-PL01-BBP2025-08-12
14897129991349CeroFrictSML011-PL01-BBP2025-08-12
04897129991281CeroFrictSML005-BB072025-08-11
04897129991304CeroFrictSML005-BB092025-08-11
04897129991311CeroFrictSML004-PY01-CC2025-08-11
04897129991335CeroFrictSML011-PL01-B2025-08-11
04897129991359CeroFrictSML011-PL02-B2025-08-11
04897129991366CeroFrictSML004-PY02-LC2025-08-11
14897129991288CeroFrictSML005-BB072025-08-11
04897129991298CeroFrictSML005-BB082025-08-11
14897129991301CeroFrictSML005-BB092025-08-11
34897129991312CeroFrictSML004-PY01-CC2025-08-11
14897129991332CeroFrictSML011-PL01-B2025-08-11
14897129991356CeroFrictSML011-PL02-B2025-08-11
14897129991363CeroFrictSML004-PY02-LC2025-08-11
04897129990468CeroFrictSML001-PT042023-04-17
04897129990475CeroFrictSML001-PT052023-04-17
04897129990482CeroFrictSML001-PT062023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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