Accuryn SmartFoley IAP UO Temp Tray System 14Fr

Basic Information

• Brand Name: Accuryn SmartFoley IAP UO Temp Tray System 14Fr
• Primary DI: 00850019755114
• Version / Model: FGS-06-IAP.14FST
• Catalog Number: FGS-06-IAP.14FST
• Company Name: POTRERO MEDICAL, INC.
• Labeler DUNS: 079428290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-30
• Public Version: 1
• Public Version Date: 2023-04-07
• Public Version Status: New
• Public Device Record Key: a9684ab7-bff9-49e0-9f69-67a0c7cc1e4c

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: 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: No
• 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
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	876.5130	2
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown		U
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63635	Multi-parameter urinary monitoring system catheter set	A collection of sterile devices intended to be used in a multi-parameter urinary monitoring system to provide continuous urinary drainage with measured collection, and to detect intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It consists of a specialized urethral catheter with distal sensors/transducers for measurement of pressure and temperature, a urinary collection cassette and collection bag, with connecting tubing. 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	10850019755111	GS1	Case	10	In Commercial Distribution
Primary	00850019755114	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221020	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	14	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 60 Degrees Celsius