Duns Number:848429929
Device Description: The Nightingale PPM3 Monitor is intended for monitoring, recording, and alarming basic vit The Nightingale PPM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
Catalog Number
179-0003
Brand Name
Nightingale Monitoring System
Version/Model Number
Nightingale PPM3
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
K130740
Product Code
MWI
Product Code Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Public Device Record Key
1975d146-b2ec-4c80-8be1-2e984c3cb6c6
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 22, 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. | 45 |