Accuryn UO/T Catheter, 16F Kit

FDA UDI

Class II (US FDA UDI)

by Potrero Medical, Inc.

Identity

Trade Name: Accuryn UO/T Catheter, 16F Kit 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-UOT.16FS 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-UOT.16FS FDA UDI
Primary DI / UDI-DI: 00868475000297 FDA UDI
510(k) Number: K153655 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 16 French FDA UDI

Accuryn UO/T Catheter, 16F Kit by Potrero Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Potrero Medical, Inc.

Sources (1)

FDA UDI 3877332d-a7dc-41c0-8bda-ebcfaff45421 38 fields · synced Jun 8, 2026