Thopaz+

Basic Information

• Brand Name: Thopaz+
• Primary DI: 07612367043304
• Version / Model: Thopaz+
• Catalog Number: 200.5718
• Company Name: Medela AG
• Labeler DUNS: 488293218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-03
• Public Version: 4
• Public Version Date: 2023-08-28
• Public Version Status: Update
• Public Device Record Key: 793e4006-b61c-4d75-aecf-4f3fb68c478d

Device Description

Thoracic suction system pump 079.1003

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
Primary	07612367043304	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141553	000