JETi All In One Sterile Kit - 6Fr

GUDID 08717648351396

WALK VASCULAR L.L.C.

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Primary Device ID08717648351396
NIH Device Record Keyd74da420-e98b-4771-8eed-798bb775eff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi All In One Sterile Kit - 6Fr
Version Model NumberWV6203A
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 Kittrue
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

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
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
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
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
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com

Device Dimensions

Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108717648351396 [Primary]
HIBCCB139WV6203A1 [Previous]

FDA Product Code

QEZAspiration Thrombectomy Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 Sterile Kit - 6Fr]

B139WV6203A2WV6203A
08717648351396WV6203A

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