Accuryn SmartFoley Tray System Foley Adapter

Basic Information

• Brand Name: Accuryn SmartFoley Tray System Foley Adapter
• Primary DI: 00850019755176
• Version / Model: FGS-06-UOT.SMCS
• Catalog Number: FGS-06-UOT.SMCS
• Company Name: POTRERO MEDICAL, INC.
• Labeler DUNS: 079428290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-29
• Public Version: 2
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: ad8656c3-43cf-4cb9-83e4-386aafabea91

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 SmartFoley is a single use device intended for short-term use (less than 30 days).

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64572	Multi-parameter urinary monitoring system connection set	A collection of noninvasive devices intended to be used to make connections in a multi-parameter urinary monitoring system during continuous urinary drainage with measured collection, and detection of intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It typically includes an electrical cable(s), tubing, and urine collection bag, and is intended to connect to a specialized urethral sensor catheter (not included) and the system control unit (not included). It is typically used in an intensive care setting to manage acute renal failure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850019755173	GS1	Case	10	In Commercial Distribution
Primary	00850019755176	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 60 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight