Duns Number:053146767
Device Description: SH 7-2 Five-in-One Connector connects tubing with inside diameters from 3/16" to 7/16". B SH 7-2 Five-in-One Connector connects tubing with inside diameters from 3/16" to 7/16". Barbed edges on each step help to prevent disconnects. Single Patient Use
Catalog Number
SH 7-2
Brand Name
SH 7-2 Five-in-One Connector
Version/Model Number
SH 7-2
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
b130ec62-cb17-4660-9529-687e5f277cf6
Public Version Date
October 21, 2020
Public Version Number
4
DI Record Publish Date
July 30, 2018
Package DI Number
M996SH725
Quantity per Package
50
Contains DI Package
M996SH720
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Heat-sealed poly bag
| 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 |