Standard BodySet® with Needleless Connectors

GUDID B101A120125XS1

115 in. (290 cm) For Use with the BodyGuard® Infusion Pump

CME AMERICA LLC

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• Primary Device ID: B101A120125XS1
• NIH Device Record Key: 69494245-9924-4a18-9d54-0f683210552a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard BodySet® with Needleless Connectors
• Version Model Number: A120-125XS
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B101A120125XS0 [Primary]
HIBCC	B101A120125XS1 [Package]; Contains: B101A120125XS0; Package: Case [16 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: 2016-08-03

On-Brand Devices [Standard BodySet® with Needleless Connectors]

• 10818666020266: 128 in. (320 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
• B101A120125XSE1: 128 in. (320 cm) For Use with the BodyGuard® Infusion Pump
• B101A120125XS1: 115 in. (290 cm) For Use with the BodyGuard® Infusion Pump