ESU Sensor ICM-000-0422

GUDID 00817688021742

I.C. MEDICAL, INC.

Surgical plume evacuation system

• Primary Device ID: 00817688021742
• NIH Device Record Key: e5733fc6-c678-4582-a38f-9cf7d4e4d655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESU Sensor
• Version Model Number: 2250
• Catalog Number: ICM-000-0422
• Company DUNS: 616182895
• Company Name: I.C. 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817688021742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932230

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

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: 2019-04-08
• Device Publish Date: 2016-09-24

On-Brand Devices [ESU Sensor]

• 00817688021742: 2250
• 00817688021711: ICM-000-0009