Rymed

GUDID 20817903010623

Bbraun 7" MacroBore High Pressure Catheter Extension Set with bonded Clear InVision-Plus

RYMED TECHNOLOGIES, LLC

Neutral-pressure needleless valve-connector

• Primary Device ID: 20817903010623
• NIH Device Record Key: c382f0d2-a46c-4274-814d-ac66adab4b05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rymed
• Version Model Number: 460213
• 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
• Phone: +15123017334
• Email: amccutchen@rymedtech.com
• Phone: +15123017334
• Email: amccutchen@rymedtech.com
• Phone: +15123017334
• Email: amccutchen@rymedtech.com
• Phone: +15123017334
• Email: amccutchen@rymedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817903010629 [Primary]
GS1	10817903010626 [Package]; Contains: 00817903010629; Package: Inner case [100 Units]; In Commercial Distribution
GS1	20817903010623 [Package]; Contains: 10817903010626; 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

[20817903010623]

Radiation Sterilization

[20817903010623]

Radiation Sterilization

[20817903010623]

Radiation Sterilization

[20817903010623]

Radiation Sterilization

[20817903010623]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-25

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