Duns Number:065762392
Device Description: Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector
Catalog Number
RE-343002U
Brand Name
Biotronix Healthcare
Version/Model Number
RE-343002U
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140237,K140237
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
415fde67-2e7e-4a0d-9e18-7adf35b9b4ad
Public Version Date
December 24, 2019
Public Version Number
2
DI Record Publish Date
October 04, 2019
Package DI Number
10850005165078
Quantity per Package
50
Contains DI Package
00850005165071
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |