AccessGUDID - DEVICE: TraumaGuard Intra-abdominal Pressure-Sensing System (00860003478721)

GUDID

Device Identifier (DI) Information

Brand Name: TraumaGuard Intra-abdominal Pressure-Sensing System
Version or Model: TraumaGuard GE Cable
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000-0260
Company Name: SENTINEL MEDICAL TECHNOLOGIES

Primary DI Number: 00860003478721
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 100036890 *Terms of Use

Device Description: The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
For Single-Use:	No
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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c6baddf-c0b9-4ad6-aa95-4eb636cef3ca
Public Version Date: July 15, 2024
Public Version Number: 1
DI Record Publish Date: July 06, 2024