FDA.reportPublic FDA data

N/A

Primary DI
04961333243341
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
KUMCS-6021SNK
Device description
REUSE BRUSH 6.0BRISTLE 210L 4.8MAX 2PC
Published
2018-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04961333243341PrimaryGS10
14961333243348Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333243341049613332433414961333243341
1496133324334814961333243348

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cleaning brush, reusableA device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length210Centimeter
Lumen/Inner Diameter4.8Millimeter
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Sound Waves""]"
Moist Heat or Steam Sterilization;High-level Disinfectant;Sound Waves

Regulatory Flags#

DUNS number
083211284
Device count
2
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
09421028490412PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490429PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490436PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490443PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490535PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490153PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490566PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490580PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490764PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028493079PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028493116PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490399PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-24
09421028490320PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-12
09421028493154PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-12
09421028490221PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028490788PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028491211PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10