Duns Number:657602459
Device Description: AIR MATTRESS CONTROLLER
Catalog Number
-
Brand Name
PRIUS
Version/Model Number
FC-PHR0025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNM
Product Code Name
Mattress, Air Flotation, Alternating Pressure
Public Device Record Key
7e368d67-4268-43ec-88fd-0e33a081fbfd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 25, 2016
Package DI Number
24717677480034
Quantity per Package
2
Contains DI Package
04717677480030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |