FDA.reportPublic FDA data

8000 Series Reusable Channel Cleaning Brush

Primary DI
00666416110100
Brand
8000 Series Reusable Channel Cleaning Brush
Company
Primed Instruments Inc
Model
8880
Catalog number
8880
Device description
Suction Well Cleaning Brush. HIBC: M45388801
Published
2017-10-23
Public version status
Update
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
00666416110100PrimaryGS10
00666416110131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00666416110100006664161101006664161101000666416110100
00666416110131006664161101316664161101310666416110131

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

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 pouch contains 10 brushes.

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
10
Premarket exempt
true
Lot or batch
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

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