Duns Number:070849038
Device Description: Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1
Catalog Number
-
Brand Name
ReddyPort
Version/Model Number
RP-531-L1
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"
Yes
For Single-Use
Yes
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
K171827,K171827,K171827,K171827
Product Code
MNS
Product Code Name
Ventilator, Continuous, Non-Life-Supporting
Public Device Record Key
327384b2-aac6-4fb4-8ede-31d6b162e013
Public Version Date
November 05, 2020
Public Version Number
1
DI Record Publish Date
October 28, 2020
Package DI Number
10850001175002
Quantity per Package
10
Contains DI Package
00850001175005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |