Rymed

GUDID 20817903010265

7" High Pressure Bifurcated MicroBore Catheter Extension Set with InVision-Plus

RYMED TECHNOLOGIES, LLC

Neutral-pressure needleless valve-connector

• Primary Device ID: 20817903010265
• NIH Device Record Key: 53a22f8a-50f0-496a-9d6e-ccf3d66bc305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rymed
• Version Model Number: RYM-5107HPB
• 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	00817903010261 [Primary]
GS1	10817903010268 [Package]; Contains: 00817903010261; Package: Inner pack [100 Units]; In Commercial Distribution
GS1	20817903010265 [Package]; Contains: 10817903010268; 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

[20817903010265]

Radiation Sterilization

[20817903010265]

Radiation Sterilization

[20817903010265]

Radiation Sterilization

[20817903010265]

Radiation Sterilization

[20817903010265]

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

On-Brand Devices [Rymed]

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• 20817903010401: 12" StandardBore I.V. Extension Set with InVision-Plus
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• 20817903010364: 60" Mini Volume Syringe Pump Extension Set with .22 Micron Filter
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• 20817903010333: Bbraun 7" StandardBore Catheter Extension Set with InVision-Plus
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• 20817903010319: 7" StandardBore Catheter Extension Set with Clear InVision-Plus
• 20817903010302: 7" StandardBore Catheter Extension Set with InVision-Plus
• 10817903010299: Bbraun 7" High Pressure Bifurcated MicroBore Catheter Extension Set with InVision-Plus
• 20817903010289: Bbraun 7" High Pressure Bifurcated MicroBore Catheter Extension Set with Clear InVision-Plus
• 20817903010272: 7" High Pressure Bifurcated MicroBore Catheter Extension Set with Clear InVision-Plus
• 20817903010265: 7" High Pressure Bifurcated MicroBore Catheter Extension Set with InVision-Plus
• 20817903010258: Bbraun 7" MacroBore High Pressure Catheter Extension Set with InVision-Plus
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• 20817903010210: Bbraun 7" MacroBore High Pressure Catheter Extension Set with Clear InVision-Plus
• 20817903010197: 7" MacroBore High Pressure Catheter Extension Set with Clear InVision-Plus
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