Accuryn Temperature Cable FGN-06-100779

GUDID 00850019755008

The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Accuryn Monitor for continuous temperature measurement.

POTRERO MEDICAL, INC.

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• Primary Device ID: 00850019755008
• NIH Device Record Key: eff0f04f-0239-4781-8d3d-fd984489e19d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuryn Temperature Cable
• Version Model Number: FGN-06-100779
• Catalog Number: FGN-06-100779
• 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	00850019755008 [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

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• 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: 2022-10-27The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Accuryn Monitor for continuous temperature measurement.
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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