Duns Number:053146767
Device Description: The SH 75-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/ The SH 75-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
Catalog Number
SH 75-BL
Brand Name
SH 75-BL Barbed Tubing Adapter
Version/Model Number
SH 75-BL - Blue
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
fc947928-62e4-4bc3-a90f-d78cf099ad83
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 31, 2017
Package DI Number
M996SH75BL5
Quantity per Package
50
Contains DI Package
M996SH75BL0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Heat-sealed polybag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |