JETi All In One Accessory Cart

GUDID 08717648351372

WALK VASCULAR L.L.C.

Electromechanical device/system transport trolley
Primary Device ID08717648351372
NIH Device Record Key72c1b32c-411b-4d39-94fb-cbc39fca6d91
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi All In One Accessory Cart
Version Model NumberWVCART
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)227-9902
EmailAV.CUSTOMERCARE@AV.ABBOTT.COM
Phone+1(800)227-9902
EmailAV.CUSTOMERCARE@AV.ABBOTT.COM
Phone+1(800)227-9902
EmailAV.CUSTOMERCARE@AV.ABBOTT.COM
Phone+1(800)227-9902
EmailAV.CUSTOMERCARE@AV.ABBOTT.COM

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108717648351372 [Primary]
HIBCCB139WVCART0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOXStand, Infusion
QEZAspiration Thrombectomy Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-16
Device Publish Date2021-12-08

On-Brand Devices [JETi All In One Accessory Cart]

B139WVCART2WVCART
08717648351372WVCART

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