| Primary Device ID | 00653160324594 |
| NIH Device Record Key | 01a2dcf6-1057-46b6-9ef9-04ba2d166d6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Centurion |
| Version Model Number | ART885 |
| Company DUNS | 017246562 |
| Company Name | CENTURION MEDICAL PRODUCTS CORPORATION |
| Device Count | 1 |
| 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 | true |
| 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 | 00653160324594 [Package] Contains: 10653160324591 Package: CASE [5 Units] In Commercial Distribution |
| GS1 | 10653160324591 [Primary] |
| OFD | Catheter introducer kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2019-02-10 |