Thoraguard

Basic Information

• Brand Name: Thoraguard
• Primary DI: 00860000436427
• Version / Model: FGN-1387
• Catalog Number: TGCM1000
• Company Name: CENTESE, INC.
• Labeler DUNS: 081331672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-07
• Public Version: 1
• Public Version Date: 2020-10-15
• Public Version Status: New
• Public Device Record Key: 5ab5e631-8ba4-4cf5-8866-47800eaf15ae

Device Description

Thoraguard Control Module

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63645	Thoracic suction pump	An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure specifically for aspiration of the pleural cavity and/or mediastinum. It is a dedicated device intended to remove fluids (e.g., blood), secretions, and air to allow for the normal expansion/function of the lungs and/or mediastinum. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., catheter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860000436424	GS1	Box	1	In Commercial Distribution
Primary	00860000436427	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181667	000