Cleo

GUDID 30610586028346

SMITHS MEDICAL MD, INC.

Electric infusion pump administration set, single-use

• Primary Device ID: 30610586028346
• NIH Device Record Key: 1b8f4e34-c7e3-442b-9a14-46cf715982d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cleo
• Version Model Number: 21-7221-24
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, INC.
• Device Count: 10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610586028342 [Unit of Use]
GS1	30610586028346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042172

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: 6
• Public Version Date: 2018-10-17
• Device Publish Date: 2016-11-16

On-Brand Devices [Cleo]

• 30610586028414: 21-7232-24
• 30610586028407: 21-7231-24
• 30610586028391: 21-7230-24
• 30610586028353: 21-7222-24
• 30610586028346: 21-7221-24
• 30610586028339: 21-7220-24