Accuryn UO/T, Smart Cath Kit

FDA UDI

Class II (US FDA UDI)

by Potrero Medical, Inc.

Identity

Trade Name: Accuryn UO/T, Smart Cath Kit FDA UDI
Generic Name: Multi-parameter urinary monitoring system connection 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.SMCS 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.SMCS FDA UDI
Primary DI / UDI-DI: 00868475000280 FDA UDI
FDA Product Code: EXY FDA UDI
GMDN Term: Multi-parameter urinary monitoring system connection set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1800 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

Yes

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

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

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 c54a89d9-9503-4d07-84a3-c0ee0bb3846f 36 fields · synced Jun 8, 2026