FDA.reportPublic FDA data

SuperDART® ONE PASS™ Validated Channel Cleaning Kit

Primary DI
00666416120925
Brand
SuperDART® ONE PASS™ Validated Channel Cleaning Kit
Company
Primed Instruments Inc
Model
9144
Catalog number
9144-25
Device description
KIT BRUSH CLEANING 5 TO 6.3MM SuperDART SQUEEGEE SUCTION WELL AND VALVE (9292 + 9992). HIBC/UPN: M45391442
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00666416120925PrimaryGS10
00666416120918Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00666416120925006664161209256664161209250666416120925
00666416120918006664161209186664161209180666416120918

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight.

Contacts#

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

Regulatory Flags#

DUNS number
254491293
Device count
25
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0066641611231980000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
0066641611239580000 Series Reusable General and Rigid Cleaning Brush050338800505033880052025-06-13
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
00666416121304SuperDART® ONE PASS™ Validated Channel Cleaning Kit93999399-252025-06-13
00666416121328SuperDART® ONE PASS™ Validated Channel Cleaning Device92339233-252025-06-13
00666416121342SuperDART® ONE PASS™ Validated Channel Cleaning Kit93339333-252025-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
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10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
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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
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