Primary Device ID | 20886333214512 |
NIH Device Record Key | 35f3667f-bc97-406f-a51f-0d040fcf39c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | One-Piece Introducer Tray with Rapid Flow Sideport |
Version Model Number | 497436 |
Catalog Number | 497436 |
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 | 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00886333214518 [Primary] |
GS1 | 20886333214512 [Package] Contains: 00886333214518 Package: Box [10 Units] In Commercial Distribution |
DRE | Dilator, Vessel, For Percutaneous Catheterization |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-07 |
Device Publish Date | 2016-09-16 |
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 |