BodyGuard® Microset w/ Non-Vented Spike Connector

GUDID B101A100163XEBS0

130 in. (330 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump

CME AMERICA LLC

Electric infusion pump administration set, single-use

• Primary Device ID: B101A100163XEBS0
• NIH Device Record Key: 68b0de68-2a66-4b0f-a0d3-66624a6cb86c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyGuard® Microset w/ Non-Vented Spike Connector
• Version Model Number: A100-163XEBS
• 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	B101A100163XEBS0 [Primary]
HIBCC	B101A100163XEBS1 [Package]; 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: 2016-08-30

On-Brand Devices [BodyGuard® Microset w/ Non-Vented Spike Connector]

• 10818666020273: 130 in. (330 cm) Microset- yellow stripe, For Use with the BodyGuard® Infusion Pump
• B101A100163XEBS0: 130 in. (330 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump