Accuryn Monitor FGN-06-2687

GUDID 00868475000235

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 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).

POTRERO MEDICAL, INC.

Urine monitoring system

Primary Device ID	00868475000235
NIH Device Record Key	34ac1edd-54d6-4547-b108-8c65aceb4d62
Commercial Distribution Status	In Commercial Distribution
Brand Name	Accuryn Monitor
Version Model Number	FGN-06-2687
Catalog Number	FGN-06-2687
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	888-635-7280
Email	xx@xx.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com
Phone	833-222-8796
Email	cs@potreromed.com

Operating and Storage Conditions

Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 81 KiloPascal and 101 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868475000235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153655

FDA Product Code

PHU	Intra-Abdominal Pressure Monitoring Device

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-02-11
Device Publish Date	2018-01-22

Devices Manufactured by POTRERO MEDICAL, INC.

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