Mindray

GUDID 10695085002987

ICU MEDICAL, INC.

Electric infusion pump administration set, single-use

• Primary Device ID: 10695085002987
• NIH Device Record Key: 901df300-c7ca-4c66-b6a3-2f1f6482aae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mindray
• Version Model Number: 0012-00-0975
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	10695085002987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912280

FDA Product Code

• FLL: Thermometer, electronic, clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-04-16
• Device Publish Date: 2016-10-13

On-Brand Devices [Mindray]

• 10695085002987: 0012-00-0975
• 30610674804906: 0206-03-0300-02