I/A Tubing

GUDID 00817688021964

I.C. MEDICAL, INC.

Surgical plume evacuation system tube

• Primary Device ID: 00817688021964
• NIH Device Record Key: 48860fcb-5d80-486d-86df-34d84806d819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I/A Tubing
• Version Model Number: ICM-000-0448
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, INC.
• Device Count: 25
• 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	00817688021346 [Unit of Use]
GS1	00817688021964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914118

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

Sterilization

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

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

Ethylene Oxide

[00817688021964]

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 [I/A Tubing]

• 00817688021964: ICM-000-0448
• 00817688021339: 2190
• 00817688021315: ICM-000-0295
• 00817688021292: ICM-000-0003