Duns Number:123160736
Device Description: G5 Mobile Replacement Receiver Kit (Medicare)
Catalog Number
-
Brand Name
Dexcom G5 Mobile Replacement Receiver Kit (Medicare)
Version/Model Number
STR-MC-001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P120005
Product Code
PQF
Product Code Name
Sensor, Glucose, Invasive, Non-Adjunctive
Public Device Record Key
f21d46b4-b610-4a60-a8d1-e9f01e5ba5b4
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
April 04, 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 |
|---|---|---|
| 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. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 72 |