Duns Number:962175894
Device Description: Compressor / Nebulizer with disposable - Private Label Theda Care at Home
Catalog Number
3655LTPL-THED
Brand Name
DeVilbiss
Version/Model Number
3655LTPL-THED
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
K020932,K020932
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
e69183d0-03e7-44af-99d7-cf03fc797626
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 21, 2017
Package DI Number
10885304001048
Quantity per Package
6
Contains DI Package
00885304001041
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |