SpeedLyser
GUDID H787128002025
SpeedLyser Infusion Catheter Basic Kit
ANGIODYNAMICS, INC.
Peripheral vascular infusion catheter| Primary Device ID | H787128002025 |
| NIH Device Record Key | 7fafd25b-f3bb-47ae-af2f-661691bba356 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeedLyser |
| Version Model Number | 12800202 |
| 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 | 15051684013055 [Secondary] |
| HIBCC | H787128002020 [Primary] |
| HIBCC | H787128002025 [Package] Contains: H787128002020 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.