Duns Number:533751681
Device Description: Water bottle and cap to be used exclusively with the Aer-O-Scope Colonoscope System
Catalog Number
MASA02474
Brand Name
Aer-O-Scope Water Bottle
Version/Model Number
Rev A
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
-
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
FDF
Product Code Name
Colonoscope And Accessories, Flexible/Rigid
Public Device Record Key
0ff94558-2fb8-4031-9d5d-d655c2907662
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
August 01, 2017
Package DI Number
17290016992035
Quantity per Package
2
Contains DI Package
07290016992038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |