JETi Pump Set

GUDID B139WVJSET11

WALK VASCULAR L.L.C.

Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set
Primary Device IDB139WVJSET11
NIH Device Record Key64686023-4ec5-4ba0-abfd-cc9751501976
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi Pump Set
Version Model NumberWV-JSET-1
Company DUNS034774488
Company NameWALK VASCULAR L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB139WVJSET10 [Primary]
HIBCCB139WVJSET11 [Package]
Contains: B139WVJSET10
Package: Carton [1 Units]
In Commercial Distribution

FDA Product Code

QEZAspiration Thrombectomy Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


[B139WVJSET11]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-25
Device Publish Date2019-06-17

On-Brand Devices [JETi Pump Set]

B139WV00100WV0010
B139WV00090WV0009
B139WVJSET11WV-JSET-1
B139WVJSET1WV-JSET

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.