Duns Number:131254971
Device Description: Portable Suction Device
Catalog Number
-
Brand Name
SSCOR VX-2 ®
Version/Model Number
2310V-230
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
82fa8f59-5354-45f1-a1e5-6487cb3c212f
Public Version Date
August 30, 2019
Public Version Number
1
DI Record Publish Date
August 22, 2019
Package DI Number
B2452310V2301
Quantity per Package
1
Contains DI Package
B2452310V2300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 24 |