Duns Number:867673159
Device Description: Sleep Flow Generator Accessories Product Description IntelliPAP 12V Adapter with Clips
Catalog Number
-
Brand Name
DeVilbiss
Version/Model Number
DV51D-696
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
-
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
K053240
Product Code
CAW
Product Code Name
Generator, oxygen, portable
Public Device Record Key
56c6d18c-4c0e-4394-9925-631c61c9572e
Public Version Date
February 17, 2020
Public Version Number
1
DI Record Publish Date
February 07, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |