Duns Number:068199363
Device Description: 24 Hour Tubing for FUJIFILM 700 Endoscopes
Catalog Number
-
Brand Name
Scope Buddy Plus Tubing
Version/Model Number
4002910
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
Yes
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
FEB
Product Code Name
Accessories, Cleaning, For Endoscope
Public Device Record Key
8c7d0fac-7859-40d1-8b4f-868c69f49baa
Public Version Date
April 06, 2022
Public Version Number
3
DI Record Publish Date
July 02, 2021
Package DI Number
40677964021983
Quantity per Package
30
Contains DI Package
40677964021976
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2999 |
2 | A medical device with a moderate to high risk that requires special controls. | 362 |