Duns Number:264351388
Device Description: The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitorin The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitoringelectrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxidepressure at the end of expiration (EtCO2), nitrous oxide concentration (%N20), partialpressure of inspired carbon dioxide, respiratory rate (RR), noninvasiveblood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired andexpired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of oxygen (FiO2) and temperature tracking.
Catalog Number
1-094-9900
Brand Name
SCHILLER
Version/Model Number
MAGLIFE Serenity
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
c1f378f4-b975-4c27-aa81-6b392496def2
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 21, 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 |