Duns Number:174959692
Device Description: Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor W Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap
Catalog Number
-
Brand Name
Nonin
Version/Model Number
8000J-WO2
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)
Yes
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
K102350,K102350,K102350
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
1df1cbde-b875-457d-b494-9bbc212e836c
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
August 24, 2016
Package DI Number
00833166003437
Quantity per Package
1
Contains DI Package
00849686073676
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Baf
| 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 |