Duns Number:849626338
Device Description: STARTER KIT MMT-7820LNA GST4C LOCKOUT US
Catalog Number
-
Brand Name
Guardian™ Connect
Version/Model Number
MMT-7820LNA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
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
f03f4a69-3ce0-437e-a4a4-1b8ec6040610
Public Version Date
September 12, 2018
Public Version Number
2
DI Record Publish Date
June 22, 2018
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 |