Duns Number:962175894
Device Description: IntelliPAP AutoBilevel w/HH - Latin America
Catalog Number
DV57D-HH-LA
Brand Name
DeVilbiss
Version/Model Number
DV57D-HH-LA
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
K112220,K112220
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
716c57b2-0b53-43ae-92a1-4f84c3c00914
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 08, 2017
Package DI Number
10885304022159
Quantity per Package
4
Contains DI Package
00885304022152
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 |