Duns Number:080216804
Device Description: Nebu-Life Hand Held Nebulizer 6cc Cup, w/ Pediatric Aerosol Elongated Mask & 7' Tube (2. Nebu-Life Hand Held Nebulizer 6cc Cup, w/ Pediatric Aerosol Elongated Mask & 7' Tube (2.1m). Pediatric. The Jet Nebulizer Bottle Set is used to administer various aerosal treatments to adults and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
Catalog Number
RTG-07106
Brand Name
Nebu-Life
Version/Model Number
RTG-07106
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
Yes
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
K091272,K091272
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
d0196cc0-acc4-4471-a602-2ffe06ae8888
Public Version Date
May 11, 2020
Public Version Number
2
DI Record Publish Date
February 25, 2019
Package DI Number
10853292007533
Quantity per Package
50
Contains DI Package
00853292007536
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |