Primary Device ID | 10846835009163 |
NIH Device Record Key | d2ffe905-c2ea-48f7-81f0-474bcf68404a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ThermoCool SmartTouch |
Version Model Number | D132701 |
Catalog Number | D132701 |
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 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 *Do not use if package is damaged |
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 *Keep Dry |
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 *Keep out of direct sunlight |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
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 *Keep out of direct sunlight |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
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 *Keep out of direct sunlight |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
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 *Keep out of direct sunlight |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
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 *Keep out of direct sunlight |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10846835009163 [Primary] |
LPB | Cardiac ablation percutaneous catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-09-27 |
Device Publish Date | 2014-09-10 |
10846835009200 | D132705 |
10846835009194 | D132704 |
10846835009187 | D132703 |
10846835009170 | D132702 |
10846835009163 | D132701 |
10846835009019 | D133603 |
10846835009002 | D133602 |
10846835008982 | D133601 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMOCOOL SMARTTOUCH 77822699 4361649 Live/Registered |
BIOSENSE WEBSTER, INC. 2009-09-09 |