Duns Number:058614483
Device Description: OxyAlert NIRSensor,Infant - Somatic,Infant Somatic Disposable Regional Oxygen Saturation S OxyAlert NIRSensor,Infant - Somatic,Infant Somatic Disposable Regional Oxygen Saturation Sensor
Catalog Number
-
Brand Name
INVOS
Version/Model Number
IS-S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 05, 2022
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091224,K091224,K091224
Product Code
MUD
Product Code Name
Oximeter, tissue saturation
Public Device Record Key
0df7277d-589e-49ad-ba6e-a6b58b4ede31
Public Version Date
September 21, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10884521552654
Quantity per Package
8
Contains DI Package
10884521211131
Package Discontinue Date
January 05, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |