SuperDART® ONE PASS™ Validated Channel Cleaning Kit 9355-25
GUDID 00666416121267
KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9253 + 9990). HIBC/UPN: M45393552
Primed Instruments Inc
Surgical instrument/endoscope cleaning utensil, single-use| Primary Device ID | 00666416121267 |
| NIH Device Record Key | 61d61199-b558-4d2b-9636-b082c0ea6a96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SuperDART® ONE PASS™ Validated Channel Cleaning Kit |
| Version Model Number | 9355 |
| Catalog Number | 9355-25 |
| Company DUNS | 254491293 |
| Company Name | Primed Instruments Inc |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00666416121267 [Unit of Use] |
| GS1 | 00666416121274 [Primary] |
FDA Product Code
| MNL | Accessories, Cleaning Brushes, For Endoscope |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-23 |
| Device Publish Date | 2025-06-13 |
On-Brand Devices [SuperDART® ONE PASS™ Validated Channel Cleaning Kit]
| 00666416121342 | KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9233 + 9990). HIBC/UPN: M45393332 |
| 00666416121304 | KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9293 + 9990). HIBC/UPN: M45393992 |
| 00666416121267 | KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9253 + 9990). HIBC/UPN: M4539355 |
| 00666416120918 | KIT BRUSH CLEANING 5 TO 6.3MM SuperDART SQUEEGEE SUCTION WELL AND VALVE (9292 + 9992). HIBC/UPN: |
Trademark Results [SuperDART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPERDART 79282326 not registered Live/Pending |
Realme Chongqing Mobile Telecommunications Corp., Ltd. 2020-01-10 |
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