Duns Number:627879687
Device Description: The AquaShield system – Pentax is intended to be used with an air or carbon dioxide (CO2) The AquaShield system – Pentax is intended 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
00711550
Brand Name
AquaShield
Version/Model Number
711550
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
5e7464d1-e471-4068-b0c5-62e99a4dcc0c
Public Version Date
June 10, 2022
Public Version Number
9
DI Record Publish Date
January 03, 2017
Package DI Number
10816765012984
Quantity per Package
25
Contains DI Package
00816765012987
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 |