Duns Number:069590113
Device Description: Used in conjunction with a syringe as an additive device for aspiration from multi-dose me Used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. systems and pre-slit septums covering injection sites.
Catalog Number
-
Brand Name
SOL-M™ Blunt Fill Needle with 5 Micron Filter
Version/Model Number
110022
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
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
eed731bc-4a14-4ce3-8fb8-5f16f59fb312
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
20818392015298
Quantity per Package
10
Contains DI Package
10818392015291
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 |