Duns Number:849626338
Device Description: PUMP MMT-722NAS PRDGM V2.4 SK US RH IPX7
Catalog Number
-
Brand Name
PARADIGM® REAL-time
Version/Model Number
MMT-722NAS
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
P980022
Product Code
MDS
Product Code Name
Sensor, glucose, invasive
Public Device Record Key
0e55f658-9919-47f0-ae55-bb1083984073
Public Version Date
October 31, 2018
Public Version Number
1
DI Record Publish Date
September 30, 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 |