BodyGuard® Microset with Filter

GUDID 00818666020009

110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump

CME AMERICA LLC

Electric infusion pump administration set, single-use

• Primary Device ID: 00818666020009
• NIH Device Record Key: 1aa185b3-38f9-4260-8755-bf45a068328e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyGuard® Microset with Filter
• Version Model Number: A120-112XSFK
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818666020009 [Primary]
GS1	10818666020006 [Package]; Package: Case [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 [BodyGuard® Microset with Filter]

• 00818666020221: 134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
• 00818666020214: 105 in. (270 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pum
• 10818666020198: 85 in. (220 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump
• 10818666020013: 110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
• 00818666020009: 110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
• B101A120160XSFK1: 110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
• B101A120160XSFE1: 134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
• B101A120112XSFK1: 110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
• B101A100164XESF0: 105 in. (270 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
• B101A100163XESF0: 85 in. (220 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump