Duns Number:174959692
Device Description: Non-Adhesive, Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQ Non-Adhesive, Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology
Catalog Number
-
Brand Name
Nonin
Version/Model Number
8004CB-NA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K090807,K132402,K090807,K132402,K090807,K132402,K090807,K132402
Product Code
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
27ef654a-febb-44bf-bc56-d3805368ce24
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
August 24, 2016
Package DI Number
00849686071412
Quantity per Package
1
Contains DI Package
00849686073362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| 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 |