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Accuryn SmartFoley IAP UO Temp Tray System 12Fr

FDA UDI

Class II (US FDA UDI)

by Potrero Medical, Inc.

Identity

Trade Name
Accuryn SmartFoley IAP UO Temp Tray System 12Fr 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 with the Accuryn Sensing Urinary Catheter (SmartFoley) – IAP UO Temp 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). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days). FDA UDI
Model / Reference
FGS-06-IAP.12FST 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 with the Accuryn Sensing Urinary Catheter (SmartFoley) – IAP UO Temp 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). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days). FDA UDI

Identifiers

Catalog Number
FGS-06-IAP.12FST FDA UDI
Primary DI / UDI-DI
00850019755107 FDA UDI
510(k) Number
K221020 FDA UDI
FDA Product Code
EZL FDA UDI
PHU FDA UDI
EXY FDA UDI
OUG 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
876.1800 FDA UDI
880.6310 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 Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 12 French FDA UDI

Category: Multi-parameter urinary monitoring system catheter set

Accuryn SmartFoley IAP UO Temp Tray System 12Fr 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.

Cleared under the same submission

K221020 also covers:

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 c917a8cd-3457-4c2c-bda5-b1e3c725bac2 38 fields · synced Jun 8, 2026