| Primary Device ID | B06751500020 |
| NIH Device Record Key | 1f6f9ea9-9396-49a0-9a72-4edeccd0addd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Model 5150-002 Tubing Set |
| Version Model Number | 5150-002 |
| Catalog Number | 5150-002 |
| Company DUNS | 010316284 |
| Company Name | CLARUS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B06751500020 [Primary] |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-22 |
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