Duns Number:141668116
Device Description: Plastic Intake Nebulizer Filters - with Heads
Catalog Number
BF016
Brand Name
Plastic Intake Nebulizer Filters - with Heads
Version/Model Number
BF016
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
-
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
JRL
Product Code Name
Unit, Filter, Membrane
Public Device Record Key
3ff9f2cf-1cb7-49fc-ba0b-9fe88ae1dda9
Public Version Date
August 15, 2018
Public Version Number
2
DI Record Publish Date
May 25, 2018
Package DI Number
10848530010109
Quantity per Package
3000
Contains DI Package
00848530010102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |