Accuryn SmartFoley UO Temp Tray System 16Fr FGS-06-UOT.16FST

GUDID 10850019755142

The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).

POTRERO MEDICAL, INC.

Multi-parameter urinary monitoring system catheter set

Primary Device ID	10850019755142
NIH Device Record Key	5e594829-9c79-4f92-b9eb-0b9dca345a83
Commercial Distribution Status	In Commercial Distribution
Brand Name	Accuryn SmartFoley UO Temp Tray System 16Fr
Version Model Number	FGS-06-UOT.16FST
Catalog Number	FGS-06-UOT.16FST
Company DUNS	079428290
Company Name	POTRERO MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
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	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com
Phone	1-833-222-8796
Email	cs@potreromed.com

Device Dimensions

Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French
Catheter Gauge	16 French

Operating and Storage Conditions

Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Handling Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019755145 [Primary]
GS1	10850019755142 [Package] Contains: 00850019755145 Package: Case [10 Units] In Commercial Distribution

FDA Product Code

EZL	Catheter, Retention Type, Balloon

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[10850019755142]

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-10-07
Device Publish Date	2021-09-29

Devices Manufactured by POTRERO MEDICAL, INC.

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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