Duns Number:780421038
Device Description: Radius-PPG Adt Adult Pulse Oximeter Adhesive Sensor
Catalog Number
-
Brand Name
Radius-PPG
Version/Model Number
4582
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"
Yes
For Single-Use
Yes
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
K183697,K183697
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
12e6591d-a570-44c9-b77c-6a738c0c5d71
Public Version Date
January 18, 2021
Public Version Number
2
DI Record Publish Date
September 03, 2020
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |