Duns Number:039631334
Device Description: Replacement Pocket Neb Nebulizer Medication Cups with Mouthpiece and Mask Adapter
Catalog Number
-
Brand Name
Pocket Neb
Version/Model Number
MVD-70-8
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142541,K142541
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
eb9b195d-435e-4be4-8501-3713b226a4c2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 26, 2017
Package DI Number
10856702006034
Quantity per Package
4
Contains DI Package
00856702006037
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |