Primary Device ID | M20682101 |
NIH Device Record Key | d1ce0ac6-af81-4369-af0f-f1b4388d144b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Guardian® II hemostasis valve |
Version Model Number | 8210 |
Company DUNS | 008999906 |
Company Name | Vascular Solutions, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com | |
Phone | 888-240-6001 |
customerservice@vasc.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M20682100 [Primary] |
HIBCC | M20682101 [Package] Contains: M20682100 Package: Box [25 Units] In Commercial Distribution |
DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2016-09-06 |
M20682110 | The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic |
M20682101 | The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic |