AV Sheath Tunneler AVST0100

GUDID 00801741090516

AV Sheath Tunneler Sterilization Cassette

Bard Peripheral Vascular, Inc.

Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller Vascular graft tunneller

• Primary Device ID: 00801741090516
• NIH Device Record Key: e731fae3-53c9-409d-b75d-72dd0a23ee9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AV Sheath Tunneler
• Version Model Number: AVST0100
• Catalog Number: AVST0100
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, Inc.
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741090516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042062

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

[00801741090516]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [AV Sheath Tunneler]

• 00801741132155: AV Sheath Tunneler
• 00801741090530: AV Sheath Tunneler Set
• 00801741090523: AV Sheath Tunneler Component, Handle
• 00801741090516: AV Sheath Tunneler Sterilization Cassette