Duns Number:080053362
Device Description: Fingertip Pulse Oximeter (iP900BP)
Catalog Number
M430N-CEWH-CMIM
Brand Name
Innovo
Version/Model Number
430C/DL-PE
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
OCH
Product Code Name
Oximeter, Infrared, Sporting, Aviation
Public Device Record Key
c2bc2202-eae9-422c-bec1-79a2853501e6
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 23, 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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 16 |