Duns Number:690632047
Catalog Number
60269
Brand Name
Pneumoclean Electrostatic Filter(5 pcs/pkg)
Version/Model Number
60269
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
Yes
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
FMZ
Product Code Name
Incubator, Neonatal
Public Device Record Key
ce0134b7-7da5-4f38-b51b-825ae0f51811
Public Version Date
January 29, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
14942962602690
Quantity per Package
5
Contains DI Package
04942962602693
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 40 |