ULPA Box Filter

GUDID 00817688021681

I.C. MEDICAL, INC.

Surgical plume evacuation system

• Primary Device ID: 00817688021681
• NIH Device Record Key: 1a585855-1af9-43c1-82ab-2a67c06999d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULPA Box Filter
• Version Model Number: ICM-000-0289
• 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: 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	00817688021674 [Primary]
GS1	00817688021681 [Package]; Contains: 00817688021674; Package: [10 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: 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 [ULPA Box Filter]

• 00817688021780: ICM-000-0460
• 00817688021681: ICM-000-0289
• 00817688021667: ICM-000-0276
• 00817688021643: ICM-000-0262