TraumaGuard Intra-abdominal Pressure-Sensing System 000-0219

GUDID 00860003478707

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

Multi-parameter urinary monitoring system catheter set

• Primary Device ID: 00860003478707
• NIH Device Record Key: d96402ab-8b26-462b-8f04-4cbfdcd92f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TraumaGuard Intra-abdominal Pressure-Sensing System
• Version Model Number: TraumaGuard Intra-abdominal Pressure-Sensing Syste
• Catalog Number: 000-0219
• Company DUNS: 100036890
• Company Name: SENTINEL MEDICAL TECHNOLOGIES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com
• Phone: 1-800-579-4910
• Email: info@sentinelmedtech.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003478707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240057

FDA Product Code

• PHU: Intra-Abdominal Pressure Monitoring Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-06

On-Brand Devices [TraumaGuard Intra-abdominal Pressure-Sensing System]

• 00860011933106: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478776: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478752: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478745: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478738: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478721: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478714: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermist
• 00860003478707: TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage cathete