Accuryn Monitor Mount with Clamp FGN-06-100202

GUDID 00850019755237

The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob. The Accuryn Monitor Mount with Clamp is an accessory to the Accuryn Monitoring System.

POTRERO MEDICAL, INC.

Urine monitoring system
Primary Device ID00850019755237
NIH Device Record Key7243e354-ebda-4d77-91cf-762d7b35cdc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuryn Monitor Mount with Clamp
Version Model NumberFGN-06-100202
Catalog NumberFGN-06-100202
Company DUNS079428290
Company NamePOTRERO MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com
Phone833-222-8796
Emailcs@potreromed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019755237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon
PHUIntra-Abdominal Pressure Monitoring Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-27
Device Publish Date2022-10-19

Devices Manufactured by POTRERO MEDICAL, INC.

00850019755015 - AccuTab2023-04-21 AccuTab is used with the Accuryn® Monitoring System that is used as a remote display for the Accuryn Monitor. The AccuData soft
10850019755104 - Accuryn SmartFoley IAP UO Temp Tray System 12Fr2023-04-07 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 14Fr2023-04-07 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 Cable2022-10-27 The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug a
00850019755206 - Accuryn Temperature Cable Adapter2022-10-27 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 Stand2022-10-27 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 Stand2022-10-27 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 Clamp2022-10-27The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob. The Accuryn Monitor Mount with Clamp is an accessory to the Accuryn Monitoring System.
00850019755237 - Accuryn Monitor Mount with Clamp2022-10-27 The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be at
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