Smoke Tubing

GUDID 00817688021810

I.C. MEDICAL, INC.

Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube

• Primary Device ID: 00817688021810
• NIH Device Record Key: d8f3c295-ee04-4c91-9139-28b4cfcecddc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smoke Tubing
• Version Model Number: ICM-000-0274
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, INC.
• Device Count: 5
• 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: true
• 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	00817688021568 [Unit of Use]
GS1	00817688021810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932230

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

Sterilization

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

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

[00817688021810]

Ethylene Oxide

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