Duns Number:867673159
Device Description: Vacu-Aide w/battery, North America
Catalog Number
7325P-D
Brand Name
Drive DeVilbiss Vacu-Aide Suction Unit
Version/Model Number
7325P-D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
JCX
Product Code Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Public Device Record Key
9392586e-40e5-47ef-b9b9-54a8bdda97d9
Public Version Date
January 17, 2022
Public Version Number
1
DI Record Publish Date
January 07, 2022
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 |