| Primary Device ID | 20886333210088 |
| NIH Device Record Key | b29e7507-e66e-4225-ad14-b12a870eb938 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procedure Tray |
| Version Model Number | 384827 |
| Catalog Number | 384827 |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, INC. |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Away from Sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333210084 [Primary] |
| GS1 | 20886333210088 [Package] Contains: 00886333210084 Package: Box [5 Units] In Commercial Distribution |
| OWL | Peripheral Catheter Insertion Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-23 |
| 00886333227167 - CLEANER Vac™ | 2024-04-25 CLEANER Vac™ Thrombectomy System - 18F OD x 115cm |
| 00886333227174 - Cleaner Vac™ | 2024-04-25 Cleaner Vac™ - 18F OD x 115cm Aspiration Catheter with Handpiece |
| 00886333227624 - Cleaner Vac™ | 2024-04-25 Cleaner Vac™ Aspiration Canister |
| 00886333225743 - Kodiak | 2023-07-10 Kodiak™ Dual Port Coaxial Introducer Kit |
| 20886333227284 - Co-Axial Introducer Needle | 2023-06-16 Co-Axial Introducer Needle 15ga x 6.8cm |
| 20886333227383 - Percutaneous Introducer | 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 25cm |
| 20886333227390 - Percutaneous Introducer | 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 45cm |
| 20886333227406 - Percutaneous Introducer | 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 65cm |