Duns Number:849626338
Device Description: SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
Catalog Number
-
Brand Name
Guardian™ Connect App
Version/Model Number
CSS7201
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
P160007
Product Code
MDS
Product Code Name
Sensor, glucose, invasive
Public Device Record Key
34c48188-5c5c-48b2-9554-7b13421aa0a9
Public Version Date
March 30, 2021
Public Version Number
2
DI Record Publish Date
August 02, 2020
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| 3 | A medical device with high risk that requires premarket approval | 1084 |