| Primary Device ID | 20886333209594 |
| NIH Device Record Key | 5453c4e0-ca4d-457b-b900-97481abe34e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Splittable Needle Introducer |
| Version Model Number | 28 GA (1.2F) x 20 mm |
| Catalog Number | 384061 |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333209590 [Primary] |
| GS1 | 20886333209594 [Package] Contains: 00886333209590 Package: Box [10 Units] In Commercial Distribution |
| LJS | Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-23 |
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| 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 |