Accuryn Monitor High Mount FGN-06-102112

GUDID 00850019755244

The Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’s bed during stationary use or transport. The Monitor High Mount can also be placed on top of the Floor Stand to raise the drainage bag up to drain the bag more easily. The Accuryn Monitor High Mount is an accessory to the Accuryn Monitoring System.

POTRERO MEDICAL, INC.

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• Primary Device ID: 00850019755244
• NIH Device Record Key: 2fc99694-7fd1-4d8b-8cce-72151f35036f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuryn Monitor High Mount
• Version Model Number: FGN-06-102112
• Catalog Number: FGN-06-102112
• 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: true
• Serial Number: false
• 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: 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
• 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
• Phone: 833-222-8796
• Email: cs@potreromed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019755244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153655

FDA Product Code

• EZL: Catheter, Retention Type, Balloon
• PHU: Intra-Abdominal Pressure Monitoring Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

Devices Manufactured by POTRERO MEDICAL, INC.

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• 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