| Primary Device ID | 10854916006833 |
| NIH Device Record Key | 3fe0e9d5-3dcb-41c4-968b-07112541d85e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MC3 Opus(tm) Vascular Access Kit |
| Version Model Number | 21030 |
| Catalog Number | 21030 |
| Company DUNS | 806687406 |
| Company Name | MICHIGAN CRITICAL CARE CONSULTANTS, INC. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10854916006833 [Primary] |
| GS1 | 20854916006847 [Package] Package: box [5 Units] In Commercial Distribution |
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2019-05-30 |
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