Bridge™ Occlusion Balloon 590-001
GUDID 00813132023263
Bridge Occlusion Catheter - 80 mm Length Balloon
Spectranetics Corporation
Intravascular occluding balloon catheter, image-guided| Primary Device ID | 00813132023263 |
| NIH Device Record Key | 85577e2c-22d8-486c-bec5-e9f1bc8ae8d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bridge™ Occlusion Balloon |
| Version Model Number | 590-001 |
| Catalog Number | 590-001 |
| Company DUNS | 151047370 |
| Company Name | Spectranetics Corporation |
| 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 | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com |
Device Dimensions
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132023263 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153530
FDA Product Code
| MJN | Catheter, Intravascular Occluding, Temporary |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
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Ethylene Oxide
[00813132023263]
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[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
[00813132023263]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-02-25 |
Devices Manufactured by Spectranetics Corporation
| 00813132029944 - Turbo-Power | 2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.0mm |
| 00813132029951 - Turbo-Power | 2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.3mm |
| 00813132029937 - CVX-300 | 2022-10-20 Excimer Laser System |
| M2041100010 - ELCA™ | 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100020 - ELCA™ | 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100030 - ELCA™ | 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100040 - ELCA™ | 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter |
| M2041140090 - ELCA™ | 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter |
Trademark Results [Bridge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRIDGE 98840100 not registered Live/Pending |
Blue Meteor, Inc. 2024-11-06 |
 BRIDGE 98657696 not registered Live/Pending |
Clarke, Dania, Lori 2024-07-19 |
 BRIDGE 98497775 not registered Live/Pending |
Bridget Mansour 2024-04-12 |
 BRIDGE 98497768 not registered Live/Pending |
Bridget Mansour 2024-04-12 |
 BRIDGE 98298315 not registered Live/Pending |
Bridge Ventures Inc. 2023-12-04 |
 BRIDGE 98298313 not registered Live/Pending |
Bridge Ventures Inc. 2023-12-04 |
 BRIDGE 98182651 not registered Live/Pending |
Alex Goodwin 2023-09-15 |
 BRIDGE 98096190 not registered Live/Pending |
Applied Materials, Inc. 2023-07-21 |
 BRIDGE 97870689 not registered Live/Pending |
RxBenefits, Inc. 2023-04-03 |
 BRIDGE 97834046 not registered Live/Pending |
The Redcliffe Group, LLC 2023-03-10 |
 BRIDGE 97586573 not registered Live/Pending |
Bridge Metaverse LLC 2022-09-11 |
 BRIDGE 97423300 not registered Live/Pending |
BRICK's Corporation 2022-05-23 |
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