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SENTINEL MEDICAL TECHNOLOGIES, LLC

Matched from indexed company URL: Sentinel Medical Technologies, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30214683263021468326SENTINEL MEDICAL TECHNOLOGIES, LLC1Y2026-01-0150 N Laura St Ste 2500 Jacksonville FL US 32202

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860003478707TraumaGuard Intra-abdominal Pressure-Sensing System - 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).1-800-579-4910info@sentinelmedtech.com
00860003478714TraumaGuard Intra-abdominal Pressure-Sensing System - The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.1-800-579-4910info@sentinelmedtech.com
00860003478721TraumaGuard Intra-abdominal Pressure-Sensing System - The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.1-800-579-4910info@sentinelmedtech.com
00860003478738TraumaGuard Intra-abdominal Pressure-Sensing System - The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.1-800-579-4910info@sentinelmedtech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3006511606086597K240057TraumaGuard Intra-abdominal Pressure Sensing SystemEZL2024-04-17
3006511817582263K210570TraumaGuard Intra-abdominal Pressure Sensing SystemPHU2021-10-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EZL12024-04-17
PHU12021-10-29

PMN#

GUDID#

TraumaGuard Intra-abdominal Pressure-Sensing System - 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).

SENTINEL MEDICAL TECHNOLOGIES

2024-07-06