Accuryn Temperature Cable Adapter FGN-06-102306

GUDID 00850019755206

A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter is an accessory of the Accuryn Monitoring System.

POTRERO MEDICAL, INC.

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• Primary Device ID: 00850019755206
• NIH Device Record Key: 22960468-026a-4504-a401-f4ad7a34fbc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuryn Temperature Cable Adapter
• Version Model Number: FGN-06-102306
• Catalog Number: FGN-06-102306
• 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: true
• 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	00850019755206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153655

FDA Product Code

• 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

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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
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• 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