Summit International SMCE-80.1.0

GUDID B346SMCE80101

80" COILED EXT SET, ID1.0xOD2.0MM

DRAGON HEART MEDICAL, INC.

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• Primary Device ID: B346SMCE80101
• NIH Device Record Key: 2e4b0807-2b60-46e2-88ed-468b83f3f769
• Commercial Distribution Discontinuation: 2024-04-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit International
• Version Model Number: SMCE-80.1.0
• Catalog Number: SMCE-80.1.0
• Company DUNS: 841522985
• Company Name: DRAGON HEART MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B346SMCE80101 [Primary]

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-11
• Device Publish Date: 2021-05-03

On-Brand Devices [Summit International ]

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• B346SMCE80151: 80" COILED EXT SET, ID1.5xOD2.5MM
• B346SMCE80101: 80" COILED EXT SET, ID1.0xOD2.0MM
• B346SMCE60151: 60" COILED EXT SET, ID1.5xOD2.5MM
• B346SMCE60101: 60" COILED EXT SET, ID1.0xOD2.0MM
• B346SMCE40151: 40" COILED EXT SET, ID1.5xOD2.5MM
• B346SMCE40101: 40" COILED EXT SET, ID1.0xOD2.0MM
• B346SMCE160151: 160" Coiled extension set
• B346R0021: Product consist of piercing spike and cover, the twist off-connector and an integrated vial adap
• B346MSCE160101: 160" COILED EXT SET, ID1.0xOD2.0MM
• B346MSCE120151: 120" COILED EXT SET, ID1.5xOD2.5MM
• B346MSCE120101: 120" COILED EXT SET, ID1.0xOD2.0MM
• B346MC8004T0: Quad-port extension set
• B346MES3601: 360" Coiled extension set