Duns Number:545348500
Catalog Number
-
Brand Name
Finger pulse oximeter
Version/Model Number
JB7239
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
3d80a158-3d02-4b08-9e22-adaf49dcde2a
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
06944249300009
Quantity per Package
24
Contains DI Package
06944249301211
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |