Duns Number:830437997
Device Description: Dual Color OLED Display Pulse Oximeter
Catalog Number
11-50DP
Brand Name
Veridian
Version/Model Number
11-50DP
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
DQA
Product Code Name
Oximeter
Public Device Record Key
0e52caea-27e9-4e35-bfa4-f26dfe31b6a9
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10845717004791
Quantity per Package
24
Contains DI Package
30845717004795
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |