AVAIL F6QRA005RT
GUDID 10846835000504
BIOSENSE WEBSTER INC.
Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use| Primary Device ID | 10846835000504 |
| NIH Device Record Key | 158d43da-aab2-4a87-accb-83fa3878aa4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVAIL |
| Version Model Number | F6QRA005RT |
| Catalog Number | F6QRA005RT |
| 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
| 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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835000504 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K892265
FDA Product Code
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
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 | 2021-01-15 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [AVAIL]
| 10846835008128 | F6QRF252RT |
| 10846835008111 | F6QRA252RT |
| 10846835007565 | F6BRA010RT |
| 10846835007442 | F5QRF252RT |
| 10846835007428 | F5QRF005RT |
| 10846835007404 | F5QRD010RT |
| 10846835007398 | F5QRA252RT |
| 10846835007381 | F5QRA005RT |
| 10846835000542 | F6QRF010RT |
| 10846835000535 | F6QRF005RT |
| 10846835000528 | F6QRD010RT |
| 10846835000511 | F6QRA010RT |
| 10846835000504 | F6QRA005RT |
Trademark Results [AVAIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVAIL 98380413 not registered Live/Pending |
NHY International Inc 2024-01-29 |
 AVAIL 98361090 not registered Live/Pending |
Zest Comics, Inc. 2024-01-17 |
 AVAIL 98046055 not registered Live/Pending |
Avnet, Inc. 2023-06-16 |
 AVAIL 98036415 not registered Live/Pending |
Avail Gear LLC 2023-06-09 |
 AVAIL 98036408 not registered Live/Pending |
Avail Gear LLC 2023-06-09 |
 AVAIL 97976969 not registered Live/Pending |
Avail, LLC 2022-11-07 |
 AVAIL 97666833 not registered Live/Pending |
Avail, LLC 2022-11-07 |
 AVAIL 97554862 not registered Live/Pending |
AIS Holding Company LLC 2022-08-18 |
 AVAIL 97554856 not registered Live/Pending |
AIS Holding Company LLC 2022-08-18 |
 AVAIL 97336147 not registered Live/Pending |
Miracle-Ear, Inc. 2022-03-29 |
 AVAIL 97234839 not registered Live/Pending |
Automatic Equipment Manufacturing Co. 2022-01-24 |
 AVAIL 90750539 not registered Live/Pending |
Smith & Wesson Inc. 2021-06-02 |
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