Endo-SPONGE Pump

Basic Information

• Brand Name: Endo-SPONGE Pump
• Primary DI: 08718104890947
• Version / Model: XS
• Catalog Number: 5526650
• 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: 72993264-a16d-44a8-8968-2319084ec053

Device Description

The Endo-SPONGE® Pump Wound Drainage Device is a compact, portable device that delivers a controlled negative pressure to a wound bed used for wound therapy.

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
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
20395	Negative-pressure wound therapy system, electric, reusable	An assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and an electrically-powered vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718104890947	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082311	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 85 – 110 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 85 – 110 KiloPascal