Accuryn Monitor

Basic Information

• Brand Name: Accuryn Monitor
• Primary DI: 00868475000235
• Version / Model: FGN-06-2687
• Catalog Number: FGN-06-2687
• Company Name: POTRERO MEDICAL, INC.
• Labeler DUNS: 079428290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-22
• Public Version: 7
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 34ac1edd-54d6-4547-b108-8c65aceb4d62

Device Description

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown		U
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63634	Multi-parameter urinary monitoring system control unit	An electrically-powered component of a multi-parameter urinary monitoring system intended to process and display measurements of urinary output, intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It is a control unit with a monitor connected to a dedicated disposable catheter set (not included) and is typically used in an intensive care setting to manage acute renal failure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868475000235	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153655	000
K221020	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 81 – 101 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 81 – 101 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius