Duns Number:006072078
Device Description: Kit containing 36-3000cc canister with aerostat filter, float valve shutoff, 18-18" connec Kit containing 36-3000cc canister with aerostat filter, float valve shutoff, 18-18" connecting tubes and 18 specimen collectors
Catalog Number
AQL-BEMIS
Brand Name
Aquilex Fluid Control System
Version/Model Number
AQL-BEMIS
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
Yes
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
7b172d9a-0e3b-4dcd-b92e-0ec881773847
Public Version Date
January 08, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-