Duns Number:022721133
Device Description: Nebulizer (Pediatric) with aerosol mask, elastic strap fixation.
Catalog Number
8905-0
Brand Name
N/A
Version/Model Number
8905-0
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K870027,K870027
Product Code
CCQ
Product Code Name
NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Public Device Record Key
0a8d6b8b-0c60-4c4b-9e24-2b7b4c62dda4
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10607411890113
Quantity per Package
50
Contains DI Package
00607411890116
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |