Duns Number:079550876
Device Description: V60 Ventilator, English,Opt: CFLEX,AVAPS
Catalog Number
1053617
Brand Name
Philips Respironics
Version/Model Number
V60
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNT
Product Code Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Public Device Record Key
418b1495-b8a9-46c8-bb57-7cbb027b71cd
Public Version Date
October 11, 2021
Public Version Number
4
DI Record Publish Date
October 22, 2015
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. | 33 |