FDA.reportPublic FDA data

TraumaGuard Intra-abdominal Pressure-Sensing System

Primary DI
00860003478707
Brand
TraumaGuard Intra-abdominal Pressure-Sensing System
Company
SENTINEL MEDICAL TECHNOLOGIES
Model
TraumaGuard Intra-abdominal Pressure-Sensing Syste
Catalog number
000-0219
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).
Published
2024-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon
PHUIntra-Abdominal Pressure Monitoring Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2
PHUIntra-Abdominal Pressure Monitoring DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240057000TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC2024-04-17EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003478707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003478707008600034787078600034787070860003478707

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter urinary monitoring system catheter setA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature5 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-579-4910info@sentinelmedtech.com

Regulatory Flags#

DUNS number
100036890
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003478714TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard Cable Universal000-02292024-07-06
00860003478721TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard GE Cable000-02602024-07-06
00860003478738TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard Philips Cable 000-02502024-07-06
00860003478745TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard Universal Reverse Cable000-02902024-07-06
00860003478752TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard Kohden Cable000-02802024-07-06
00860003478776TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard Spacelab cable000-03102024-07-06
00860011933106TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard GE-Carescape Cable000-03202024-07-06

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