Duns Number:053469565
Device Description: Venting Needle Filtered with 0.2 Micron Hydrophobic filter, white filter housing, 20 gauge Venting Needle Filtered with 0.2 Micron Hydrophobic filter, white filter housing, 20 gauge x 1.5" stainless steel non-coring needle, sterile, individual blister pack, box of 100
Catalog Number
31-20
Brand Name
Venting Needle
Version/Model Number
31-20
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"
-
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
b028d26e-482b-4447-b36f-0a5393225dcc
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
August 22, 2016
Package DI Number
B21231202
Quantity per Package
100
Contains DI Package
B21231201
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |