Duns Number:627879687
Device Description: The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) sourc The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures.
Catalog Number
00711541
Brand Name
AquaShield
Version/Model Number
00711541
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"
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
FEQ
Product Code Name
PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Public Device Record Key
16d7d8a6-8501-426f-9194-3a18b23fd650
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 17, 2016
Package DI Number
10816765012304
Quantity per Package
25
Contains DI Package
00816765012307
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 |