Duns Number:884718776
Device Description: NEBULIZER SET, PEDIATRIC (CONTAINS: PEDIATRIC ELONGATED MASK, NEBULIZER BOTTLE 6ML, 7' OXY NEBULIZER SET, PEDIATRIC (CONTAINS: PEDIATRIC ELONGATED MASK, NEBULIZER BOTTLE 6ML, 7' OXYGEN TUBE W/ STANDARD-UNIVERSAL CONNECTORS)
Catalog Number
-
Brand Name
GLOBAL HEALTHCARE
Version/Model Number
63-565
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
e0aa16df-609c-4c36-b18e-12465732b386
Public Version Date
August 06, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
40872237004858
Quantity per Package
50
Contains DI Package
00872237004850
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. | 62 |