| Primary Device ID | 10850019755111 |
| NIH Device Record Key | a9684ab7-bff9-49e0-9f69-67a0c7cc1e4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accuryn SmartFoley IAP UO Temp Tray System 14Fr |
| Version Model Number | FGS-06-IAP.14FST |
| Catalog Number | FGS-06-IAP.14FST |
| Company DUNS | 079428290 |
| Company Name | POTRERO MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019755114 [Primary] |
| GS1 | 10850019755111 [Package] Contains: 00850019755114 Package: Case [10 Units] In Commercial Distribution |
| EZL | Catheter, Retention Type, Balloon |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10850019755111]
Ethylene Oxide
[10850019755111]
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[10850019755111]
Ethylene Oxide
[10850019755111]
Ethylene Oxide
[10850019755111]
Ethylene Oxide
[10850019755111]
Ethylene Oxide
[10850019755111]
Ethylene Oxide
[10850019755111]
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Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-07 |
| Device Publish Date | 2023-03-30 |
| 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 | 2023-04-07The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) – IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days). |
| 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 |