ClearLumen II Pump Set

GUDID B139WV06PS020

WALK VASCULAR L.L.C.

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• Primary Device ID: B139WV06PS020
• NIH Device Record Key: e96b1abb-dc1c-49df-ac17-0759f6a372ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearLumen II Pump Set
• Version Model Number: WV06PS02
• 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: true
• 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	B139WV06PS020 [Primary]

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

Ethylene Oxide

[B139WV06PS020]

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 [ClearLumen II Pump Set]

• B139WV06PS020: WV06PS02
• B139WV06PS010: WV06PS01