Duns Number:962175894
Device Description: Vacu-Aide Homecare Suction Unit, Latin America
Catalog Number
7305D-LA
Brand Name
DeVilbiss
Version/Model Number
7305D-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
-
Product Code
JCX
Product Code Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Public Device Record Key
8d45d930-05df-4517-ab6d-3d210f5ae66d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 23, 2016
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 197 |