Duns Number:627879687
Device Description: The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
Catalog Number
710300
Brand Name
CO2MPACT
Version/Model Number
710300
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
-
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
K111648
Product Code
FCX
Product Code Name
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
Public Device Record Key
b28b1af6-4eb8-49cb-ab7f-d1161a2acdca
Public Version Date
March 31, 2020
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |