Duns Number:116722847
Device Description: Clever Choice Universal Fit Reusable Nebulizer KitAdult SizeContains Nebulizer Mask with e Clever Choice Universal Fit Reusable Nebulizer KitAdult SizeContains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x Filters, Mouth Piece, and Air Tube with Connectors.
Catalog Number
-
Brand Name
Clever Choice
Version/Model Number
Universal Fit Reusable Nebulizer Kit
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
885e7e2d-083c-4579-8bb4-2257ff6f405b
Public Version Date
April 12, 2022
Public Version Number
1
DI Record Publish Date
April 04, 2022
Package DI Number
10850002860488
Quantity per Package
75
Contains DI Package
00850002860481
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. | 3 |