Duns Number:123160736
Device Description: G5 Mobile Receiver Adult Pink
Catalog Number
-
Brand Name
Dexcom G5 Mobile Receiver
Version/Model Number
MT22719-PNK
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
P120005
Product Code
MDS
Product Code Name
Sensor, Glucose, Invasive
Public Device Record Key
bef11626-45d7-45cd-a2af-92f8a6051eb7
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
November 09, 2015
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 |