Duns Number:013112308
Device Description: I.V. INFUSION SET, LUER LOCK, NO NEEDLE, STERILE. 1EA.
Catalog Number
VINLL
Brand Name
Rospital Productos Medicos
Version/Model Number
VINLL
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
58d929fe-f49e-40a7-bddc-0147ff4a65c7
Public Version Date
October 26, 2020
Public Version Number
1
DI Record Publish Date
October 18, 2020
Package DI Number
10812460028640
Quantity per Package
400
Contains DI Package
00812460028643
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |