SpeedLyser
GUDID H787128002015
SpeedLyser Infusion Catheter Basic Kit
ANGIODYNAMICS, INC.
Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter| Primary Device ID | H787128002015 |
| NIH Device Record Key | 044a7c1b-75c8-4135-958f-d5e41e21ed40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeedLyser |
| Version Model Number | 12800201 |
| 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 | |
| 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
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 21 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684013048 [Secondary] |
| HIBCC | H787128002010 [Primary] |
| HIBCC | H787128002015 [Package] Contains: H787128002010 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033443
FDA Product Code
| KRA | Catheter, continuous flush |
| QEY | Mechanical thrombolysis catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-13 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [SpeedLyser]
| H787128002045 | SpeedLyser Infusion Catheter Basic Kit |
| H787128002025 | SpeedLyser Infusion Catheter Basic Kit |
| H787128002015 | SpeedLyser Infusion Catheter Basic Kit |
Trademark Results [SpeedLyser]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEEDLYSER 76544680 2917862 Live/Registered |
AngioDynamics, Inc. 2003-09-15 |
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