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Accuryn SmartFoley 3-Way UO Tray System 18Fr

FDA UDI

Class II (US FDA UDI)

by Potrero Medical, Inc.

Identity

Trade Name
Accuryn SmartFoley 3-Way UO Tray System 18Fr FDA UDI
Generic Name
Multi-parameter urinary monitoring system catheter set FDA UDI
Device Name
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). FDA UDI
Model / Reference
FGS-06-3UO.18FS FDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
FGS-06-3UO.18FS FDA UDI
Primary DI / UDI-DI
00850019755169 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Multi-parameter urinary monitoring system catheter set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 18 French FDA UDI

Category: Multi-parameter urinary monitoring system catheter set

Accuryn SmartFoley 3-Way UO Tray System 18Fr by Potrero Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-parameter urinary monitoring system catheter set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Potrero Medical, Inc.

Sources (1)

  • FDA UDI a8405478-45d6-48db-b6e6-b93f4bc85697 36 fields · synced Jun 8, 2026