Rymed

GUDID 10817903010299

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

RYMED TECHNOLOGIES, LLC

Neutral-pressure needleless valve-connector

• Primary Device ID: 10817903010299
• NIH Device Record Key: 90865320-c2e5-40e7-b238-2ea7983bd911
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rymed
• Version Model Number: 460202
• 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	00817903010292 [Primary]
GS1	10817903010299 [Package]; Contains: 00817903010292; Package: Inner case [100 Units]; In Commercial Distribution
GS1	20817903010296 [Package]; 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

[10817903010299]

Radiation Sterilization

[10817903010299]

Radiation Sterilization

[10817903010299]

Radiation Sterilization

[10817903010299]

Radiation Sterilization

[10817903010299]

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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• 20817903010753: Bbraun 7" MicroBore Catheter Extension set with Clear Junior InVision-Plus
• 20817903010746: Bbraun InVision-Plus Junior Clear Needleless IV Connector
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• 20817903010623: Bbraun 7" MacroBore High Pressure Catheter Extension Set with bonded Clear InVision-Plus
• 20817903010609: InVision-Plus Clear Junior Needleless IV Connector
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• 20817903010432: Double 4-Way stopcock with 28" tubing and bonded Invision-Plus
• 20817903010425: 4” MicroBore T-Port Extension Set with clear InVision-Plus
• 20817903010418: 4" T-Port MicroBore Extension Set with InVision-Plus
• 20817903010401: 12" StandardBore I.V. Extension Set with InVision-Plus
• 20817903010395: 15" MacroBore Catheter Extension Set with InVision-Plus
• 20817903010388: 4" Bifurcated MicroBore Extension Set with InVision-Plus
• 20817903010371: 60" MacroBore Extension Set
• 20817903010364: 60" Mini Volume Syringe Pump Extension Set with .22 Micron Filter
• 20817903010357: 60" Mini Volume Syringe Pump Extension Set
• 20817903010340: 4" Trifurcated MicroBore Extension Set with One .22 Micron Filter on 8" Tubing
• 20817903010333: Bbraun 7" StandardBore Catheter Extension Set with InVision-Plus
• 20817903010326: Bbraun 7" StandardBore Catheter Extension Set with Clear InVision-Plus
• 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
• 20817903010241: 7" MacroBore High Pressure Catheter Extension Set with InVision-Plus CS
• 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
• 20817903010180: Bbraun 7" MicroBore Catheter Extension set with InVision-Plus
• 20817903010173: Bbraun 7" MicroBore Catheter Extension set with Clear InVision-Plus
• 20817903010166: 7" MicroBore Catheter Extension set with Clear InVision-Plus
• 20817903010159: 7" MicroBore Catheter Extension set with InVision-Plus
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• 20817903010043: Bbraun In Vision Plus Clear, Needleless IV Connector
• 20817903010036: InVision-Plus Junior Needleless IV Connector
• 20817903010029: InVision-Plus CS, Needleless IV Connector