FDA.reportPublic FDA data

8000 Series Reusable Channel Cleaning Brush

Primary DI
M45381900
Brand
8000 Series Reusable Channel Cleaning Brush
Company
Primed Instruments Inc
Model
8190
Catalog number
8190
Device description
Reusable Tapered Cleaning Brush. HIBC/UPN: M45381900
Published
2018-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
M45381900PrimaryHIBCC0

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reusable Cleaning Brushes should be stored in a sterile package at room temperature in a dry clean area away from direct sunlight. Each device is individually packaged.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-877-565-0565info@primedinstruments.com

Regulatory Flags#

DUNS number
254491293
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006664161214969000 Series Disposable Channel Cleaning Brush050338800305033880032026-07-08
006664161220119000 Series Disposable Channel Cleaning Brush050338800405033880042026-07-08
0066641611231980000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
0066641611239580000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
00666416120925SuperDART® ONE PASS™ Validated Channel Cleaning Kit91449144-252025-06-13
00666416121144SuperDART® ONE PASS™ Validated Channel Cleaning Device92539253-252025-06-13
00666416121274SuperDART® ONE PASS™ Validated Channel Cleaning Kit93559355-252025-06-13
00666416121298SuperDART® ONE PASS™ Validated Channel Cleaning Device92939293-252025-06-13
00666416121311SuperDART® ONE PASS™ Validated Channel Cleaning Kit93999399-252025-06-13
00666416121335SuperDART® ONE PASS™ Validated Channel Cleaning Device92339233-252025-06-13
00666416121359SuperDART® ONE PASS™ Validated Channel Cleaning Kit93339333-252025-06-13
006664161214589000 Series Disposable Channel Cleaning Brush050338800405033880042025-06-13
006664161217319000 Series Disposable Channel Cleaning Brush050338800405033880042025-06-13
006664161217489000 Series Disposable Channel Cleaning Brush050338800205033880022025-06-13
1066641611231680000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
0066641611065080000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
00666416120918SuperDART® ONE PASS™ Validated Channel Cleaning Kit91449144-252025-06-13
00666416121137SuperDART® ONE PASS™ Validated Channel Cleaning Device92539253-252025-06-13
00666416121267SuperDART® ONE PASS™ Validated Channel Cleaning Kit93559355-252025-06-13
00666416121281SuperDART® ONE PASS™ Validated Channel Cleaning Device92939293-252025-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006664161214969000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
006664161220119000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
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
06936603225691Disposable Cleaning BrushYangzhou Fartley Medical Instrument Technology Co., LtdMNL2024-01-30
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