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, 3 Meter
Catalog Number
-
Brand Name
Nonin
Version/Model Number
8000J-3
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
-
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
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
1b8e2243-48fa-4a2a-91dd-54a8e2e39603
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
August 24, 2016
Package DI Number
00833166002188
Quantity per Package
1
Contains DI Package
00849686074604
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 |