FDA UDI
In Commercial Distribution
🇺🇸 United States
Life Sensing Instruments, Inc.
DI: 00857769008040
·
Model: TrensCenter 6.100
·
LIFE SENSING INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Life Sensing Instruments, Inc.
- Primary DI
- 00857769008040
- Version / Model
- TrensCenter 6.100
- Company Name
- LIFE SENSING INSTRUMENTS, INC.
- Labeler DUNS
- 080677893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-05
- Public Version
- 1
- Public Version Date
- 2023-11-13
- Public Version Status
- New
- Public Device Record Key
- 8c946fd8-5e34-494c-939a-f56bde239c68
Device Description
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16231 | Electrocardiograph, professional, multichannel | A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857769008040 | GS1 |
Customer Contacts
- Phone
- 8008461279
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K896967 | 000 |