Accuryn SmartFoley IAP UO Temp Tray System 14Fr FGS-06-IAP.14FST

GUDID 10850019755111

The 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).

POTRERO MEDICAL, INC.

Multi-parameter urinary monitoring system catheter set
Primary Device ID10850019755111
NIH Device Record Keya9684ab7-bff9-49e0-9f69-67a0c7cc1e4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuryn SmartFoley IAP UO Temp Tray System 14Fr
Version Model NumberFGS-06-IAP.14FST
Catalog NumberFGS-06-IAP.14FST
Company DUNS079428290
Company NamePOTRERO MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com
Phone1-833-222-8796
Emailcs@potreromed.com

Device Dimensions

Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019755114 [Primary]
GS110850019755111 [Package]
Contains: 00850019755114
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

[10850019755111]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-07
Device Publish Date2023-03-30

Devices Manufactured by POTRERO MEDICAL, INC.

00850019755015 - AccuTab2023-04-21 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 12Fr2023-04-07 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 14Fr2023-04-07The 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 14Fr2023-04-07 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 Cable2022-10-27 The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug a
00850019755206 - Accuryn Temperature Cable Adapter2022-10-27 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 Stand2022-10-27 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 Stand2022-10-27 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 Clamp2022-10-27 The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be at
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.