JETi Pump Set WV0009

GUDID B139WV00090

WALK VASCULAR L.L.C.

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• Primary Device ID: B139WV00090
• NIH Device Record Key: 5cc0aa47-b245-4fe5-bafd-c61b95761d3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETi Pump Set
• Version Model Number: WV0009
• Catalog Number: WV0009
• Company DUNS: 034774488
• Company Name: WALK VASCULAR L.L.C.
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 607 Millimeter of Mercury and 810 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B139WV00090 [Primary]

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

[B139WV00090]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-24

On-Brand Devices [JETi Pump Set]

• B139WV00100: WV0010
• B139WV00090: WV0009
• B139WVJSET11: WV-JSET-1
• B139WVJSET1: WV-JSET