Accuryn Monitor High Mount & Floor Stand

Basic Information

• Brand Name: Accuryn Monitor High Mount & Floor Stand
• Primary DI: 00850019755251
• Version / Model: FGN-06-102111
• Catalog Number: FGN-06-102111
• Company Name: POTRERO MEDICAL, INC.
• Labeler DUNS: 079428290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-19
• Public Version: 3
• Public Version Date: 2023-08-17
• Public Version Status: Update
• Public Device Record Key: 435d62bd-2813-4f33-8038-d9130883c37b

Device Description

A set of one Accuryn Monitor High Mount and one Accuryn Floor Stand

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: No
• Has Lot/Batch Number: Yes
• 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
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

GMDN Terms

Code	Name	Definition	Implantable	Status
61434	Portable active medical device mount	A device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850019755251	GS1

Customer Contacts

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