JETi Pump Set WV0010

GUDID B139WV00100

WALK VASCULAR L.L.C.

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Primary Device IDB139WV00100
NIH Device Record Keyea16e22e-aec1-4bde-890b-2b8c62152854
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi Pump Set
Version Model NumberWV0010
Catalog NumberWV0010
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
HIBCCB139WV00100 [Primary]

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


[B139WV00100]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-24

On-Brand Devices [JETi Pump Set]

B139WV00100WV0010
B139WV00090WV0009
B139WVJSET11WV-JSET-1
B139WVJSET1WV-JSET

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