AccuTab FGN-06-101581
GUDID 00850019755015
AccuTab is used with the Accuryn® Monitoring System that is used as a remote display for the Accuryn Monitor. The AccuData software on the tablet cannot control the monitor. AccuTab only displays data.
POTRERO MEDICAL, INC.
Multi-parameter urinary monitoring system catheter set| Primary Device ID | 00850019755015 |
| NIH Device Record Key | 54cfce24-3106-42a1-a2a0-ae02313e813d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuTab |
| Version Model Number | FGN-06-101581 |
| Catalog Number | FGN-06-101581 |
| Company DUNS | 079428290 |
| Company Name | POTRERO MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com | |
| Phone | 1-833-222-8796 |
| cs@potreromed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019755015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221020
FDA Product Code
| EZL | Catheter, Retention Type, Balloon |
| OUG | Medical Device Data System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-21 |
| Device Publish Date | 2023-04-13 |
Devices Manufactured by POTRERO MEDICAL, INC.
| 00850019755015 - AccuTab | 2023-04-21AccuTab is used with the Accuryn® Monitoring System that is used as a remote display for the Accuryn Monitor. The AccuData software on the tablet cannot control the monitor. AccuTab only displays data. |
| 00850019755015 - AccuTab | 2023-04-21 AccuTab is used with the Accuryn® Monitoring System that is used as a remote display for the Accuryn Monitor. The AccuData soft |
| 10850019755104 - Accuryn SmartFoley IAP UO Temp Tray System 12Fr | 2023-04-07 The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine out |
| 10850019755111 - Accuryn SmartFoley IAP UO Temp Tray System 14Fr | 2023-04-07 The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine out |
| 00850019755008 - Accuryn Temperature Cable | 2022-10-27 The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug a |
| 00850019755206 - Accuryn Temperature Cable Adapter | 2022-10-27 A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Ac |
| 00850019755213 - Accuryn Monitor Short Floor Stand | 2022-10-27 The Accuryn Monitor Short Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationar |
| 00850019755220 - Accuryn Monitor Floor Stand | 2022-10-27 The Accuryn Monitor Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationary use. |
| 00850019755237 - Accuryn Monitor Mount with Clamp | 2022-10-27 The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be at |
Trademark Results [AccuTab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUTAB 90420506 not registered Live/Pending |
Potrero Medical, Inc. 2020-12-28 |
 ACCUTAB 86588234 4851071 Live/Registered |
Stefan Solvell 2015-04-06 |
 ACCUTAB 79212820 5537674 Live/Registered |
SIGVARIS AG 2017-05-23 |
 ACCUTAB 75859102 2441651 Dead/Cancelled |
Sundown Plastics, L.L.C. 1999-11-29 |
 ACCUTAB 74402946 1866290 Dead/Cancelled |
GTCO Corporation 1993-06-18 |
 ACCUTAB 74047109 1672287 Dead/Cancelled |
PENFORD PRODUCTS CO. 1990-04-09 |
 ACCUTAB 73297699 1235421 Dead/Cancelled |
Market Facts, Inc. 1981-02-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.