AngioDynamics
GUDID H965251880
AngioVac Circuit Pack
NAVILYST MEDICAL, INC.
Cardiopulmonary bypass system tubing set| Primary Device ID | H965251880 |
| NIH Device Record Key | c7bdf5cb-e92c-4ea9-8d03-537ccc156253 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioDynamics |
| Version Model Number | 25188 |
| Company DUNS | 809699023 |
| Company Name | NAVILYST 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684019859 [Secondary] |
| HIBCC | H965251880 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142607
FDA Product Code
| DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
On-Brand Devices [AngioDynamics]
| H7877001059370 | Software Module (RoHS Compliant) RITA Model 1500X RF Generator |
| H965457861 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457851 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457841 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457831 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457821 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457811 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457791 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457781 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457771 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457761 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457751 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457741 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457731 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457721 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457711 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457701 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457691 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457681 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457671 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457661 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457651 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457641 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457631 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457621 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457611 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457601 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457591 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457581 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457571 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457561 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457551 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457541 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457531 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457521 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457511 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457501 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457491 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965457481 | Mini Stick MAX Coaxial Microintroducer Kit |
| H965251990 | AngioVac Circuit Pack |
| H965251880 | AngioVac Circuit Pack |
| H965251870 | AngioVac Circuit Pack |
| H965251860 | AngioVac Cannula |
| H965251850 | AngioVac Cannula |
| H965251840 | AngioVac Cannula |
| H965251830 | AngioVac Extracorporeal Circuit Pack |
| H965914300 | Namic Inflation Device Kit |
| H965914250 | Namic Inflation Device Kit |
| H965914240 | Namic Inflation Device Kit |
| H965914230 | Namic Inflation Device Kit |
Trademark Results [AngioDynamics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIODYNAMICS 87099675 5119513 Live/Registered |
AngioDynamics, Inc. 2016-07-11 |
 ANGIODYNAMICS 77786077 3749761 Live/Registered |
Angiodynamics, Inc. 2009-07-21 |
 ANGIODYNAMICS 76497558 2822666 Live/Registered |
AngioDynamics, Inc. 2003-03-17 |
 ANGIODYNAMICS 74255742 1804291 Dead/Cancelled |
ANGIODYNAMICS, INC. 1992-03-16 |
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