Duns Number:202659140
Device Description: The CO2 Endoscopic Insufflator Inline Tubing Set is intended to connect a CO2 source (insu The CO2 Endoscopic Insufflator Inline Tubing Set is intended to connect a CO2 source (insufflator) and a sterile water source (water bottle) to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.
Catalog Number
710426
Brand Name
NA
Version/Model Number
710426
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
K123047,K123047
Product Code
FCX
Product Code Name
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
Public Device Record Key
0802e877-cdda-41ea-8487-7714e98d48dd
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 17, 2016
Package DI Number
10816765013073
Quantity per Package
24
Contains DI Package
00816765013076
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |