Duns Number:713565195
Device Description: Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians.Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
BS-3
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
K213195,K213195
Product Code
FDA
Product Code Name
Enteroscope and accessories
Public Device Record Key
e3caeee3-1fde-4a7d-a4c3-70e6d408c4ea
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 30, 2022
Package DI Number
14547410463436
Quantity per Package
10
Contains DI Package
04547410463439
Package Discontinue Date
-
Package Status
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 | 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 |