← Back to catalogue

TraumaGuard Intra-abdominal Pressure-Sensing System

FDA UDI

Class U (US FDA UDI)

by Sentinel Medical Technologies, LLC

Identity

Trade Name
TraumaGuard Intra-abdominal Pressure-Sensing System FDA UDI
Generic Name
Multi-parameter urinary monitoring system catheter set FDA UDI
Device Name
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. 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 TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days). FDA UDI
Model / Reference
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter FDA UDI
Description
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. 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 TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days). FDA UDI

Identifiers

Catalog Number
000-0219 FDA UDI
Primary DI / UDI-DI
00860003478707 FDA UDI
510(k) Number
K240057 FDA UDI
FDA Product Code
PHU FDA UDI
EZL FDA UDI
GMDN Term
Multi-parameter urinary monitoring system catheter set FDA UDI

Classification

Device Class
U 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

No

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
MRI Safety
MR Conditional FDA UDI

Category: Multi-parameter urinary monitoring system catheter set

TraumaGuard Intra-abdominal Pressure-Sensing System by Sentinel Medical Technologies, LLC — Class U — FDA UDI — listed in FDA GUDID

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sentinel Medical Technologies, LLC

Sources (1)

  • FDA UDI d96402ab-8b26-462b-8f04-4cbfdcd92f88 37 fields · synced Jun 8, 2026