Duns Number:264351388
Device Description: SpO2 Sensor for Maglife Serenity
Catalog Number
0-13-0040
Brand Name
SCHILLER
Version/Model Number
SpO2 Sensor wireless
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K023195
Product Code
MWI
Product Code Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Public Device Record Key
356bcfa1-d944-4db1-8fc7-09c2afa850a5
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
November 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |