Duns Number:177266558
Device Description: This is the Device Identifier for the single unit retail version of the color doctor blood This is the Device Identifier for the single unit retail version of the color doctor blood pressure monitor.
Catalog Number
-
Brand Name
Color Doctor
Version/Model Number
Retail Unit
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
27d9df28-d816-4e8c-9551-89b649531a39
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 26, 2017
Package DI Number
20097298016077
Quantity per Package
12
Contains DI Package
10097298016070
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
12 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 |