Duns Number:079550876
Device Description: Kit,O2 Transport, Cart Mntg,NIST
Catalog Number
989805648741
Brand Name
PHILIPS
Version/Model Number
1109881
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)
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
9bb9eeb0-d400-4e53-ab52-8e1d9764906d
Public Version Date
December 07, 2020
Public Version Number
2
DI Record Publish Date
September 22, 2020
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 |