Duns Number:116979417
Device Description: The Telserve® Data Management System is an accessory to blood glucose monitoring systems f The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management.
Catalog Number
-
Brand Name
Telserve® Data Management System
Version/Model Number
DMS
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110571
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
92b47afb-4d9a-42e5-9989-f23c636675f4
Public Version Date
March 19, 2019
Public Version Number
1
DI Record Publish Date
March 11, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |