Duns Number:627879687
Device Description: The AquaShield system CO2 – Fujifilm is to be used with an air or carbon dioxide (CO2) sou The AquaShield system CO2 – Fujifilm is to be used with an air or carbon dioxide (CO2) source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures.
Catalog Number
00711553
Brand Name
AquaShield
Version/Model Number
00711553
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
K163424,K182258,K191559,K163424,K182258,K191559
Product Code
FEQ
Product Code Name
PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Public Device Record Key
16c47cb6-6d21-4e90-9ee2-c4b60eb58e33
Public Version Date
June 10, 2022
Public Version Number
10
DI Record Publish Date
June 30, 2017
Package DI Number
10816765013332
Quantity per Package
25
Contains DI Package
00816765013335
Package Discontinue Date
March 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |