Smoke Tubing

GUDID 00817688021520

I.C. MEDICAL, INC.

Surgical plume evacuation system tube

• Primary Device ID: 00817688021520
• NIH Device Record Key: 7117c07a-c17b-4cc1-a073-02f45505103d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smoke Tubing
• Version Model Number: ICM-000-0098
• 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: 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	00817688021513 [Primary]
GS1	00817688021520 [Package]; Contains: 00817688021513; Package: [25 Units]; In Commercial Distribution

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: true

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 [Smoke Tubing]

• 00817688021957: ICM-000-0269
• 00817688021810: ICM-000-0274
• 00817688021582: ICM-000-0347
• 00817688021544: ICM-000-0236
• 00817688021520: ICM-000-0098