AngioVac
GUDID 15051684025973
AngioVac F18 85 Cannula
ANGIODYNAMICS, INC.
Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous| Primary Device ID | 15051684025973 |
| NIH Device Record Key | 14f46e28-3e16-44ba-b520-b93507ef7f18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioVac |
| Version Model Number | 25-200 |
| Company DUNS | 079105071 |
| Company Name | ANGIODYNAMICS, 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 | 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 |
Customer Support Contacts
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com |
Device Dimensions
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Length | 105 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684025973 [Secondary] |
| HIBCC | H965252000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212386
FDA Product Code
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-18 |
| Device Publish Date | 2021-11-10 |
On-Brand Devices [AngioVac]
| H965251940 | AngioVac C180 with Obturator |
| H965251930 | AngioVac C20 with Obturator |
| 15051684025973 | AngioVac F18 85 Cannula |
Trademark Results [AngioVac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIOVAC 77651391 3765000 Live/Registered |
ANGIODYNAMICS, INC. 2009-01-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.