Duns Number:080677893
Device Description: Software which displays a patient's vital signs as part of the HTS820 patient-monitoring s Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
Catalog Number
-
Brand Name
Life Sensing Instruments, Inc.
Version/Model Number
TrensCenter 5.300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K896967
Product Code
DSI
Product Code Name
Detector And Alarm, Arrhythmia
Public Device Record Key
53d55292-08d8-495b-9a92-f560e3d1d27a
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 12, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |