Duns Number:108999095
Device Description: Advantage Pulse Oximeter,Fingertip, Disp pkg
Catalog Number
2200
Brand Name
Advantage™
Version/Model Number
2200
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
K161560,K161560,K161560
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
bc6a7394-460a-493d-9d55-629299023f03
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
October 17, 2018
Package DI Number
00634782564964
Quantity per Package
10
Contains DI Package
00634782864965
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |