Duns Number:713565195
Device Description: This product is intended to supply CO2 gas and feed water to clean lenses in the gastroint This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
CT-11G
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCX
Product Code Name
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
Public Device Record Key
ffd880e3-508e-469e-b944-d7d6874211ef
Public Version Date
July 04, 2022
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
14547410331605
Quantity per Package
1
Contains DI Package
04547410331608
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |