| Primary Device ID | 20813079020213 |
| NIH Device Record Key | cd930807-3931-45a0-b01e-3819e3070e28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Tear-Away Vascular Introducer Set |
| Version Model Number | 7011 |
| Catalog Number | 7011 |
| Company DUNS | 788472314 |
| Company Name | REMINGTON MEDICAL, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Catheter Gauge | 11 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813079020219 [Primary] |
| GS1 | 10813079020216 [Package] Contains: 00813079020219 Package: Inner Carton [10 Units] In Commercial Distribution |
| GS1 | 20813079020213 [Package] Contains: 10813079020216 Package: Shipping Carton [6 Units] In Commercial Distribution |
| DYB | INTRODUCER, CATHETER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
[20813079020213]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-11-10 |
| 20813079020213 | 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 |
| 10813079020209 | 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 |
| 20813079020190 | 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 |
| 10813079020186 | 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 |
| 10813079020179 | 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 |
| 10813079020162 | 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 |