Duns Number:848429929
Device Description: The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on a The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
Catalog Number
91331-NF
Brand Name
DM4
Version/Model Number
91331-NF
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"
Yes
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
K150620
Product Code
MWI
Product Code Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Public Device Record Key
6d972ead-00ee-40aa-b771-4aa322777ac5
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
June 01, 2019
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. | 45 |