FDA UDI
In Commercial Distribution
🇺🇸 United States
TraumaGuard Intra-abdominal Pressure-Sensing System
DI: 00860003478738
·
Model: TraumaGuard Philips Cable
·
SENTINEL MEDICAL TECHNOLOGIES
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TraumaGuard Intra-abdominal Pressure-Sensing System
- Primary DI
- 00860003478738
- Version / Model
- TraumaGuard Philips Cable
- Catalog Number
- 000-0250
- Company Name
- SENTINEL MEDICAL TECHNOLOGIES
- Labeler DUNS
- 100036890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-06
- Public Version
- 1
- Public Version Date
- 2024-07-15
- Public Version Status
- New
- Public Device Record Key
- cefc8991-b6d5-4220-992e-84f6986b7688
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHL | Powered Exoskeleton | Physical Medicine | 890.3480 | 2 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | 876.5130 | 2 |
| EXY | Uroflowmeter | Gastroenterology, Urology | 876.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003478738 | GS1 |
Customer Contacts
- Phone
- 1-800-579-4910
- [email protected]