JETi All In One Suction Tubing

GUDID B139WVHAND1

WALK VASCULAR L.L.C.

Surgical irrigation/aspiration tubing set

• Primary Device ID: B139WVHAND1
• NIH Device Record Key: 86055880-4f74-4df8-ad9e-23cea33b30a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETi All In One Suction Tubing
• Version Model Number: WVHAND
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B139WVHAND0 [Primary]
HIBCC	B139WVHAND1 [Package]; Contains: B139WVHAND0; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201998

FDA Product Code

• QEZ: Aspiration Thrombectomy Catheter

Sterilization

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

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

[B139WVHAND1]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

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