Duns Number:537208717
Device Description: The pulse oximeter is a portable, non-invasive device for monitoring the oxygen content of The pulse oximeter is a portable, non-invasive device for monitoring the oxygen content of blood (SpO2) and pulse rate.
Catalog Number
1905
Brand Name
ri-fox N, pulse oximeter
Version/Model Number
1905
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
K070371
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
04eb3042-da37-4d8a-a225-5a746c5beab0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |