ThermoCool SmartTouch D133601
GUDID 10846835008982
BIOSENSE WEBSTER INC.
Cardiac radio-frequency ablation system catheter| Primary Device ID | 10846835008982 |
| NIH Device Record Key | 4fb9c269-b415-49f5-a21c-99aa5e1e75f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThermoCool SmartTouch |
| Version Model Number | D133601 |
| Catalog Number | D133601 |
| Company DUNS | 020163218 |
| Company Name | BIOSENSE WEBSTER 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835008982 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030031
FDA Product Code
| LPB | Cardiac ablation percutaneous 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 | 4 |
| Public Version Date | 2021-09-27 |
| Device Publish Date | 2014-09-10 |
On-Brand Devices [ThermoCool SmartTouch]
| 10846835009200 | D132705 |
| 10846835009194 | D132704 |
| 10846835009187 | D132703 |
| 10846835009170 | D132702 |
| 10846835009163 | D132701 |
| 10846835009019 | D133603 |
| 10846835009002 | D133602 |
| 10846835008982 | D133601 |
Trademark Results [ThermoCool SmartTouch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMOCOOL SMARTTOUCH 77822699 4361649 Live/Registered |
BIOSENSE WEBSTER, INC. 2009-09-09 |
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