Rymed

GUDID 20817903010807

7” Microbore QuadPort Extension Set with check valves

RYMED TECHNOLOGIES, LLC

Intravenous administration tubing extension set

• Primary Device ID: 20817903010807
• NIH Device Record Key: adb284af-6be2-4e22-83ee-946c63eb4eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rymed
• Version Model Number: RYM-3107CV4
• Company DUNS: 079219081
• Company Name: RYMED TECHNOLOGIES, LLC
• 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: +15123017334
• Email: amccutchen@rymedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817903010803 [Primary]
GS1	10817903010800 [Package]; Contains: 00817903010803; Package: Inner pack [100 Units]; In Commercial Distribution
GS1	20817903010807 [Package]; Contains: 10817903010800; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991653

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

[20817903010807]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-25

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