Duns Number:013649151
Catalog Number
989803153291
Brand Name
MODULE,WIRELESS SPO2,3160,N1
Version/Model Number
989803153291
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2016
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
74f5e491-c318-41a3-97cb-82f2063058a0
Public Version Date
March 11, 2021
Public Version Number
5
DI Record Publish Date
September 30, 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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 650 |
U | Unclassified | 4 |