Hybrid Dressing

Basic Information

• Brand Name: Hybrid Dressing
• Primary DI: 00849405001669
• Version / Model: UP-D1530
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Labeler DUNS: 006616130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-31
• Public Version: 1
• Public Version Date: 2024-08-08
• Public Version Status: New
• Public Device Record Key: cb63653f-2a1d-4faa-b63e-30032468072e

Device Description

The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30 cm), XLR8 Port Pad (XP-1012, XP-1013) and 1 piece transparent film 26 cm x 30 cm cut into 5 pieces is a single patient use, disposable, non-invasive kit designed to be used along with recommended Genadyne NPWT pumps. The kit is intended to be used on moderate to low severity wounds.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
47406	Negative-pressure wound therapy system foam dressing, non-antimicrobial	A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849405001669	GS1