TraumaGuard Intra-abdominal Pressure-Sensing System

Basic Information

• Brand Name: TraumaGuard Intra-abdominal Pressure-Sensing System
• Primary DI: 00860003478707
• Version / Model: TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
• Catalog Number: 000-0219
• Company Name: SENTINEL MEDICAL TECHNOLOGIES
• Labeler DUNS: 100036890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-06
• Public Version: 1
• Public Version Date: 2024-07-15
• Public Version Status: New
• Public Device Record Key: d96402ab-8b26-462b-8f04-4cbfdcd92f88

Device 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).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown		U
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63635	Multi-parameter urinary monitoring system catheter set	A collection of sterile devices intended to be used in a multi-parameter urinary monitoring system to provide continuous urinary drainage with measured collection, and to detect intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It consists of a specialized urethral catheter with distal sensors/transducers for measurement of pressure and temperature, a urinary collection cassette and collection bag, with connecting tubing. It is typically used in an intensive care setting to manage acute renal failure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003478707	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240057	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 60 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight