Duns Number:174959692
Device Description: Fiber Optic Pulse Oximeter Sensor
Catalog Number
-
Brand Name
Nonin
Version/Model Number
8000FI-30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071415,K071415
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
32f310ea-1ee3-44d4-b47f-2bc106d201c0
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
August 24, 2016
Package DI Number
00833166000733
Quantity per Package
1
Contains DI Package
00849686074208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
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. | 130 |