| Primary Device ID | M45388801 |
| NIH Device Record Key | 038c6671-e442-47b0-a9fd-8c0398a637a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 8000 Series Reusable Channel Cleaning Brush |
| Version Model Number | 8880 |
| Catalog Number | 8880 |
| Company DUNS | 254491293 |
| Company Name | Primed Instruments Inc |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com | |
| Phone | 1-877-565-0565 |
| info@primedendo.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Reusable 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. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M45388800 [Unit of Use] |
| HIBCC | M45388801 [Primary] |
| MNL | Accessories, Cleaning Brushes, For Endoscope |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
[M45388801]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2018-11-20 |
| 00666416110124 | Reusable Channel Cleaning Micro Brush. HIBC/UPN: M45387030 |
| 00666416110117 | Reusable Channel Cleaning Micro Brush. HIBC/UPN: M45387010 |
| 00666416110100 | Suction Well Cleaning Brush. HIBC: M45388801 |
| 00666416110094 | Suction Well Cleaning Brush. HIBC/UPN: M45388802 |
| 00666416110087 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381950 |
| 00666416110070 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381900 |
| 00666416110063 | Reusable Tapered Cleaning Brush: Double Ended. HIBC/UPN: M45381820 |
| 00666416110056 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381800 |
| 00666416110049 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381700 |
| 00666416110032 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381600 |
| 00666416110025 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381150 |
| 00666416110018 | Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070 |
| M45388801 | Suction Well Cleaning Brush. HIBC: M45388801 |