Duns Number:177266558
Device Description: This is the device entry for the deluxe mail order version of the color doctor blood press This is the device entry for the deluxe mail order version of the color doctor blood pressure monitor.
Catalog Number
-
Brand Name
Color Doctor
Version/Model Number
Mail Order (Deluxe)
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
8ef5205a-0f15-4bf0-af28-5262f9349231
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 26, 2017
Package DI Number
10097298016520
Quantity per Package
24
Contains DI Package
00097298016523
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
24 pack master
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |