Duns Number:849626338
Device Description: PRODUCT SFTWR MMT-7333WW PERSONAL 14.6A
Catalog Number
-
Brand Name
CareLink™ Personal
Version/Model Number
MMT-7333WW
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PHV
Product Code Name
Continuous glucose monitor retrospective data analysis software
Public Device Record Key
df910ffb-7d18-4d74-b095-68f16e8b91c5
Public Version Date
August 16, 2022
Public Version Number
6
DI Record Publish Date
March 07, 2021
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 |