BodyGuard® ColorVision® Pole-mount Charger without

GUDID B101150313XVA0

CME AMERICA LLC

General-purpose infusion pump, line-powered

• Primary Device ID: B101150313XVA0
• NIH Device Record Key: 456f8972-c0dc-4509-b24a-5dd486f8204c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyGuard® ColorVision® Pole-mount Charger without
• Version Model Number: 150-313XVA
• Company DUNS: 002125419
• Company Name: CME AMERICA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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
HIBCC	B101150313XVA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042696

FDA Product Code

• MEA: Pump, Infusion, Pca

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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