BodyGuard BodySet

GUDID 10818666020433

26 in. (66 cm) - Blue Stripe

CME AMERICA LLC

Electric infusion pump administration set, single-use

• Primary Device ID: 10818666020433
• NIH Device Record Key: d166d4c1-f4ef-4d40-9b88-a9d0db84593b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyGuard BodySet
• Version Model Number: A120-160SAS
• 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: 303-936-4948
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818666020436 [Primary]
GS1	10818666020433 [Package]; Contains: 00818666020436; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-08-01

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