AV Sheath Tunneler AVST0100

GUDID 00801741090516

AV Sheath Tunneler Sterilization Cassette

Bard Peripheral Vascular, Inc.

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