CMExpress® Microbore Set

GUDID 10818666020129

106 in. (269 cm) CMExpress Microbore Set For Use with the CMExpress® Infusion Pump

CME AMERICA LLC

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• Primary Device ID: 10818666020129
• NIH Device Record Key: c353b346-a9f2-472f-99e2-b745fa53d852
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMExpress® Microbore Set
• Version Model Number: A120-161C
• Company DUNS: 002125419
• Company Name: CME AMERICA 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: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818666020122 [Primary]
GS1	10818666020129 [Package]; Contains: 00818666020122; Package: 50 [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042696

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-15

On-Brand Devices [CMExpress® Microbore Set]

• 10818666020310: 80 in. (200 cm) Set - Blue Stripe, For Use with the CMExpress® Infusion Pump
• 10818666020297: 80 in. (200 cm) Microbore Set - Blue Stripe, For Use with the CMExpress® Infusion Pump
• 10818666020129: 106 in. (269 cm) CMExpress Microbore Set For Use with the CMExpress® Infusion Pump
• B101A120161C1: 106 in. (269 cm) CMExpress Microbore Set For Use with the CMExpress® Infusion Pump
• B101A120160CY1: 80 in. (200 cm) For Use with the CMExpress® Infusion Pump
• B101A120160CRV1: 80 in. (200 cm) For Use with the CMExpress® Infusion Pump
• B101A120160C1: 80 in. (200 cm) For Use with the CMExpress® Infusion Pump