PRESTO ID4030

GUDID 10801741095006

PRESTO™ Inflation Device

Bard Peripheral Vascular, Inc.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 10801741095006
• NIH Device Record Key: 68712ade-f255-4be5-a8f4-2a801f063ad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTO
• Version Model Number: ID4030
• Catalog Number: ID4030
• 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: 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741095009 [Primary]
GS1	10801741095006 [Package]; Contains: 00801741095009; Package: CA [5 Units]; In Commercial Distribution

FDA Product Code

• MAV: Syringe, balloon inflation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-19

Devices Manufactured by Bard Peripheral Vascular, Inc.

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• 20801741201503 - Trek: 2023-06-09 Trek™ Sterile Sleeve
• 00801741213922 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 3.5mm x 100mm, 130cm Catheter
• 00801741213939 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 3.5mm x 120mm, 130cm Catheter
• 00801741213946 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 3.5mm x 150mm, 130cm Catheter
• 00801741213953 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 4.0mm x 20mm, 130cm Catheter
• 00801741213960 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 4.0mm x 40mm, 130cm Catheter