ClearLumen Peripheral Saline Drive Unit

GUDID B139WVSDU01021

WALK VASCULAR L.L.C.

Thrombectomy suction catheter

• Primary Device ID: B139WVSDU01021
• NIH Device Record Key: bd39175f-ee3a-4255-b0e4-aff334257cd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearLumen Peripheral Saline Drive Unit
• Version Model Number: WVSDU0102
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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 Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Millimeter of Mercury and 681 Millimeter of Mercury

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B139WVSDU01021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163051

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-08

Devices Manufactured by WALK VASCULAR L.L.C.

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• 08717648351372 - JETi All In One Accessory Cart: 2021-12-16
• 08717648351389 - JETi All In One Non-Sterile Kit: 2021-12-16
• 08717648351396 - JETi All In One Sterile Kit - 6Fr: 2021-12-16
• 08717648351402 - JETi All In One Sterile Kit - 8Fr: 2021-12-16
• B139WV1500A2 - JETi All In One Non-Sterile Kit: 2021-09-20
• B139WV6203A2 - JETi All In One Sterile Kit - 6Fr: 2021-09-20
• B139WV8803A2 - JETi All In One Sterile Kit - 8Fr: 2021-09-20