GORE PROPATEN Vascular Graft Pediatric Shunt HPT350005A

GUDID H373HPT350005A3

HEP PED SHUNT T3.5MM X 5CM US

W. L. Gore & Associates, Inc.

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• Primary Device ID: H373HPT350005A3
• NIH Device Record Key: db239be8-5edb-42a5-8bb4-b8388b3c52fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE PROPATEN Vascular Graft Pediatric Shunt
• Version Model Number: HPT350005A
• Catalog Number: HPT350005A
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132606399 [Primary]
HIBCC	H373HPT350005A3 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062161

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE PROPATEN Vascular Graft Pediatric Shunt]

• H373HPT350015A3: HEP PED SHUNT T3.5MM X 15CM US
• 00733132606412: HEP PED SHUNT T3.5MM X 10CM US
• H373HPT350005A3: HEP PED SHUNT T3.5MM X 5CM US
• H373HPT060015A3: HEP PED SHUNT T6MM X 15CM US
• H373HPT050015A3: HEP PED SHUNT T5MM X 15CM US
• 00733132606337: HEP PED SHUNT T5MM X 10CM US
• H373HPT050005A3: HEP PED SHUNT T5MM X 5CM US
• H373HPT040015A3: HEP PED SHUNT T4MM X 15CM US
• 00733132606276: HEP PED SHUNT T4MM X 10CM US
• 00733132606252: HEP PED SHUNT T4MM X 5CM US
• 00733132606238: HEP PED SHUNT T3MM X 15CM US
• 00733132606214: HEP PED SHUNT T3MM X 10CM
• 00733132606191: HEP PED SHUNT T3MM X 5CM US