Exsudex disposable canister

Basic Information

• Brand Name: Exsudex disposable canister
• Primary DI: 08718104890954
• Version / Model: Exsudex Disposable canister, 300 cc with filter and fixed non-sterile tube
• Catalog Number: 5526653
• Company Name: Meditop B.V.
• Labeler DUNS: 387209518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-17
• Public Version: 1
• Public Version Date: 2025-10-27
• Public Version Status: New
• Public Device Record Key: a9eeb39f-252f-4626-8307-da0998530ada

Device Description

The Exsudex® Disposable Canister has the following features and is intended to be used together with the Endo-SPONGE® Pump wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube with clamb and luer-lock connector - Dissolving sachet solidifying agent

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718104890954	GS1
Package	08718104891104	GS1	Box	16	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	300	Milliliter