Summit Medical 10

GUDID B346R0011

NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper,

DRAGON HEART MEDICAL, INC.

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• Primary Device ID: B346R0011
• NIH Device Record Key: f592e766-4f63-4005-b93c-396ee487f7a5
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit Medical
• Version Model Number: R001
• Catalog Number: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B346R0011 [Primary]
HIBCC	B346R00129 [Package]; Package: [50 Units]; Discontinued: 2023-12-31; In Commercial Distribution

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: 2018-10-04
• Device Publish Date: 2018-09-03

Devices Manufactured by DRAGON HEART MEDICAL, INC.

• B346MES3601 - Summit International: 2021-05-12 360" Coiled extension set
• B346MC8004T0 - Summit International: 2021-05-11 Quad-port extension set
• B346MSCE120101 - Summit International: 2021-05-11 120" COILED EXT SET, ID1.0xOD2.0MM
• B346MSCE120151 - Summit International: 2021-05-11 120" COILED EXT SET, ID1.5xOD2.5MM
• B346MSCE160101 - Summit International: 2021-05-11 160" COILED EXT SET, ID1.0xOD2.0MM
• B346R0021 - Summit International: 2021-05-11 Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution
• B346SMCE160151 - Summit International: 2021-05-11 160" Coiled extension set
• B346SMCE40101 - Summit International: 2021-05-11 40" COILED EXT SET, ID1.0xOD2.0MM