FDA.reportPublic FDA data

TraumaGuard Intra-abdominal Pressure-Sensing System

Primary DI
00860003478745
Brand
TraumaGuard Intra-abdominal Pressure-Sensing System
Company
SENTINEL MEDICAL TECHNOLOGIES
Model
TraumaGuard Universal Reverse Cable
Catalog number
000-0290
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.
Published
2024-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003478745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003478745008600034787458600034787450860003478745

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
100036890
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003478707TraumaGuard Intra-abdominal Pressure-Sensing SystemTraumaGuard Intra-abdominal Pressure-Sensing Syste000-02192024-07-06
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
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10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
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10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
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