Duns Number:069590113
Device Description: SOL-M™ Tube Holder with Luer Lock Adapter
Catalog Number
-
Brand Name
SOL-M™ Holder with Male Luer Lock Adapter
Version/Model Number
110201050003
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"
Yes
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
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
59e120a7-3b0d-4a4d-acac-82226d15bf80
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
July 03, 2018
Package DI Number
20818392018152
Quantity per Package
4
Contains DI Package
10818392018155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 161 |