Duns Number:527945351
Device Description: Reusable Adult SpO2 Sensor for Use with Commander III device.
Catalog Number
-
Brand Name
None
Version/Model Number
S100A-090103-6
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
9915f14f-33e9-461e-803e-e39b9a4eae52
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
66900234100025
Quantity per Package
125
Contains DI Package
06900234100023
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. | 1 |