Thoraguard TGCM1000

GUDID 10860000436424

Thoraguard Control Module

CENTESE, INC.

Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump Thoracic suction pump

• Primary Device ID: 10860000436424
• NIH Device Record Key: 5ab5e631-8ba4-4cf5-8866-47800eaf15ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoraguard
• Version Model Number: FGN-1387
• Catalog Number: TGCM1000
• Company DUNS: 081331672
• Company Name: CENTESE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com
• Phone: 888-220-0040
• Email: customerservice@centese.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000436427 [Primary]
GS1	10860000436424 [Package]; Contains: 00860000436427; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181667

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-15
• Device Publish Date: 2020-10-07

On-Brand Devices [Thoraguard]

• 10860000436424: Thoraguard Control Module
• 10860000436417: Thoraguard Drainage Kit
• 10860000436400: Thoraguard Chest Tube Kit, 20 Fr
• 00860000436441: Thoraguard Chest Tube Kit, 28 Fr