AccessGUDID - DEVICE: TraumaGuard Intra-abdominal Pressure-Sensing System (00860003478707)

GUDID

Device Identifier (DI) Information

Brand Name: TraumaGuard Intra-abdominal Pressure-Sensing System
Version or Model: TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000-0219
Company Name: SENTINEL MEDICAL TECHNOLOGIES

Primary DI Number: 00860003478707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 100036890 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHU	Intra-Abdominal Pressure Monitoring Device
EZL	Catheter, Retention Type, Balloon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240057	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 60 Degrees Celsius
Storage Environment Temperature: between 5 and 60 Degrees Celsius
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d96402ab-8b26-462b-8f04-4cbfdcd92f88
Public Version Date: July 15, 2024
Public Version Number: 1
DI Record Publish Date: July 06, 2024