Duns Number:177939027
Device Description: Masimo Infant SpO2 Adhesive Sensors, 3 ft.
Catalog Number
-
Brand Name
Masimo
Version/Model Number
1861
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080424,K080424
Product Code
NLF
Product Code Name
Oximeter, Reprocessed
Public Device Record Key
a621dd0e-1d37-453e-ba4e-af5e9c3c50ad
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
30817357021418
Quantity per Package
20
Contains DI Package
10817357021414
Package Discontinue Date
March 19, 2021
Package Status
Not 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |