Duns Number:306032491
Device Description: Single use infusion set for subcutaneous infusion. The infusion set must be used as descr Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Catalog Number
-
Brand Name
Neria Guard
Version/Model Number
702080-5229
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"
-
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
K192647,K192647,K192647
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
8f9acc3a-68d5-47e7-8d53-b8a9ab75624f
Public Version Date
February 03, 2020
Public Version Number
1
DI Record Publish Date
January 24, 2020
Package DI Number
05705244022003
Quantity per Package
54
Contains DI Package
05705244021990
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |