Thoraguard TGCM1000

GUDID 10860000436424

Thoraguard Control Module

CENTESE, INC.

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