Duns Number:796083392
Device Description: Black Tubing, Natural, 3/16 in. - 3/8 in
Catalog Number
-
Brand Name
Black Tubing, Natural
Version/Model Number
BT00-0100
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
MON
Product Code Name
System, Hemodialysis, Remote Accessories
Public Device Record Key
4c3de161-0779-47dd-bf43-36f29effea8d
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
August 30, 2019
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 | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |