Duns Number:066689993
Device Description: BODYMED NEBULIZER KIT WITH PEDIATRIC MASK, INCLUDING A DISPOSABLE PEDIATRIC MASK, 6CC MEDI BODYMED NEBULIZER KIT WITH PEDIATRIC MASK, INCLUDING A DISPOSABLE PEDIATRIC MASK, 6CC MEDICATION CUP, AND TUBING.
Catalog Number
-
Brand Name
BodyMed
Version/Model Number
BDMNEBPMK
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
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
b6c68198-05c8-4415-83f6-aadcbede916d
Public Version Date
July 14, 2022
Public Version Number
1
DI Record Publish Date
July 06, 2022
Package DI Number
20815991024676
Quantity per Package
100
Contains DI Package
00815991024672
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |