Duns Number:867673159
Device Description: Panda Pediatric Neb w/ Disp NK, no carry bag
Catalog Number
-
Brand Name
Drive
Version/Model Number
MQ6004
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTI
Product Code Name
Compressor, air, portable
Public Device Record Key
ba1b362a-9776-4524-8eb1-3d8b39915e9c
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
10822383579204
Quantity per Package
8
Contains DI Package
00822383579207
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |