Duns Number:058614483
Device Description: Adult SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidie Adult SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
MAXAR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K033973,K033973
Product Code
NLF
Product Code Name
OXIMETER, REPROCESSED
Public Device Record Key
eada5e90-ef32-432d-81e0-f8493dfe33f0
Public Version Date
April 19, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10884522040105
Quantity per Package
24
Contains DI Package
20884522040102
Package Discontinue Date
-
Package Status
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 |