Duns Number:063997360
Device Description: LDR Pediatric Nebulizer System Betty the Pig
Catalog Number
5238506
Brand Name
LEADER
Version/Model Number
5238506
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043238,K043238
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
627dacb3-92aa-430b-9fc2-12a43783e90d
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 23, 2017
Package DI Number
50096295128784
Quantity per Package
6
Contains DI Package
00096295128789
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |