| Primary Device ID | 00859911004887 |
| NIH Device Record Key | 6b13e148-b6f2-49c2-a0dd-d05260ea4046 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OtoClear® Aquabot® Kit |
| Version Model Number | 7270 |
| Catalog Number | 7270 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
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| Phone | +1(800)551-7096 |
| Bionix@bionix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911004887 [Primary] |
| KCP | SYRINGE, ENT |
| LRD | Applicator, Ent Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-17 |
| Device Publish Date | 2022-01-07 |
| 00859911004894 | OtoClear Powered by Aquabot, 5 |
| 00859911004887 | OtoClear Powered by Aquabot, 20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OTOCLEAR 75852332 2423172 Live/Registered |
Bionix Development Corporation 1999-11-18 |