Duns Number:123160736
Device Description: Dexcom G4 Professional Receiver Shield Pack
Catalog Number
-
Brand Name
Dexcom G4 Professional Receiver Shield Pack
Version/Model Number
MT22428
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P120005,P120005
Product Code
MDS
Product Code Name
Sensor, Glucose, Invasive
Public Device Record Key
7dde1148-aec5-4eb5-8e22-89160e68562c
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 11, 2014
Package DI Number
10386270000139
Quantity per Package
4
Contains DI Package
00386270000132
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shield 4 Pack Bundle
| 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 |