Duns Number:401738638
Catalog Number
-
Brand Name
Suction bag, backflow valve, 3000 ml
Version/Model Number
570187-3
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
Yes
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
c76c84b0-1b52-4ee9-8170-16723d5af953
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 05, 2018
Package DI Number
06418685062925
Quantity per Package
6
Contains DI Package
06418685062918
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Delivery box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |