Duns Number:713565195
Device Description: This product is intended to be used in combination with FUJIFILM gastrointestinal endoscop This product is intended to be used in combination with FUJIFILM gastrointestinal endoscopes and a FUJIFILM endoscopic CO2 regulator to deliver CO2 gas and water.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
WT-604G
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
644f60b8-0aaa-4627-a223-543184cdec5f
Public Version Date
July 23, 2018
Public Version Number
1
DI Record Publish Date
June 20, 2018
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 | 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 |