Duns Number:021217115
Device Description: Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients
Catalog Number
-
Brand Name
Welldoc
Version/Model Number
v1.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K190013
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
4f2f45ad-0420-4ce4-8cf8-638e12c0165e
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
April 14, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |