UniFuse
GUDID 15051684013925
UniFuse Infusion System w/ Cooper Wire
Angiodynamics, Inc.
Peripheral vascular intervention infusion catheter| Primary Device ID | 15051684013925 |
| NIH Device Record Key | 0471536e-4efd-4d58-8b88-c10ef2e397d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UniFuse |
| Version Model Number | 12401820 |
| Company DUNS | 079252781 |
| 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
Device Dimensions
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 1.43 Millimeter |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684013925 [Primary] |
| HIBCC | H787124018200 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163356
FDA Product Code
| KRA | Catheter, continuous flush |
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 | 2024-09-16 |
| Device Publish Date | 2024-09-06 |
On-Brand Devices [UniFuse]
| H787124018445 | UniFuse Infusion System w/ Cooper Wire |
| H787124018435 | UniFuse Infusion System w/ Cooper Wire |
| H787124018425 | UniFuse Infusion System w/ Cooper Wire |
| H787124018415 | UniFuse Infusion System w/ Cooper Wire |
| H787124018385 | UniFuse Infusion System w/ Cooper Wire |
| H787124018375 | UniFuse Infusion System w/ Cooper Wire |
| H787124018365 | UniFuse Infusion System w/ Cooper Wire |
| H787124018355 | UniFuse Infusion System w/ Cooper Wire |
| H787124018345 | UniFuse Infusion System w/ Cooper Wire |
| H787124018335 | UniFuse Infusion System w/ Cooper Wire |
| H787124018325 | UniFuse Infusion System w/ Cooper Wire |
| H787124018315 | UniFuse Infusion System w/ Cooper Wire |
| H787124018305 | UniFuse Infusion System w/ Cooper Wire |
| H787124018295 | UniFuse Infusion System w/ Cooper Wire |
| H787124018285 | UniFuse Infusion System w/ Cooper Wire |
| H787124018275 | UniFuse Infusion System w/ Cooper Wire |
| H787124018265 | UniFuse Infusion System w/ Cooper Wire |
| H787124018255 | UniFuse Infusion System w/ Cooper Wire |
| H787124018245 | UniFuse Infusion System w/ Cooper Wire |
| H787124018235 | UniFuse Infusion System w/ Cooper Wire |
| H787124018215 | UniFuse Infusion System w/ Cooper Wire |
| H787124018205 | UniFuse Infusion System w/ Cooper Wire |
| H787124018195 | UniFuse Infusion System w/ Cooper Wire |
| H787124018185 | UniFuse Infusion System w/ Cooper Wire |
| H787124018175 | UniFuse Infusion System w/ Cooper Wire |
| H787124018165 | UniFuse Infusion System w/ Cooper Wire |
| H787124018155 | UniFuse Infusion System w/ Cooper Wire |
| H787124018145 | UniFuse Infusion System w/ Cooper Wire |
| H787124018135 | UniFuse Infusion System w/ Cooper Wire |
| H787124018125 | UniFuse Infusion System w/ Cooper Wire |
| H787124018115 | UniFuse Infusion System w/ Cooper Wire |
| H787124018105 | UniFuse Infusion System w/ Cooper Wire |
| H787124018095 | UniFuse Infusion System w/ Cooper Wire |
| H787124018085 | UniFuse Infusion System w/ Cooper Wire |
| H787124018065 | UniFuse Infusion System w/ Cooper Wire |
| H787124018055 | UniFuse Infusion System w/ Cooper Wire |
| H787124018045 | UniFuse Infusion System w/ Cooper Wire |
| H787124018035 | UniFuse Infusion System w/ Cooper Wire |
| H787124018025 | UniFuse Infusion System w/ Cooper Wire |
| H787124018015 | UniFuse Infusion System w/ Cooper Wire |
| H787124018225 | UniFuse Infusion System w/ Cooper Wire |
| H787124018075 | UniFuse Infusion System w/ Cooper Wire |
| 15051684014144 | UniFuse Infusion System w/ Cooper Wire |
| H787124018430 | UniFuse Infusion System w/ Cooper Wire |
| 15051684014120 | UniFuse Infusion System w/ Cooper Wire |
| H787124018410 | UniFuse Infusion System w/ Cooper Wire |
| 15051684014106 | UniFuse Infusion System w/ Cooper Wire |
| 15051684014090 | UniFuse Infusion System w/ Cooper Wire |
| 15051684014083 | UniFuse Infusion System w/ Cooper Wire |
| 15051684014076 | UniFuse Infusion System w/ Cooper Wire |
Trademark Results [UniFuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIFUSE 98227681 not registered Live/Pending |
C.R. Daniels, Inc. 2023-10-17 |
 UNIFUSE 85631746 4278911 Live/Registered |
BIRD DOG DISTRIBUTORS, LLC 2012-05-22 |
 UNIFUSE 75799239 2484403 Dead/Cancelled |
UNIFUSE LLC 1999-09-15 |
 UNIFUSE 75408545 not registered Dead/Abandoned |
E-Tek Dynamics, Inc. 1997-12-19 |
 UNIFUSE 75030394 2076969 Live/Registered |
AZZ WSI LLC 1995-12-06 |
 UNIFUSE 75030393 2076968 Live/Registered |
AZZ WSI LLC 1995-12-06 |
 UNIFUSE 74201743 1712237 Dead/Cancelled |
Reynolds Metals Company 1991-09-09 |
 UNIFUSE 72022045 0658061 Dead/Expired |
BEDDING MANUFACTURERS ASSOCIATES, INC. 1957-01-03 |
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