Vcare Alpha

Basic Information

• Brand Name: Vcare Alpha
• Primary DI: 07290111491306
• Version / Model: Wound Dressing Kit 20x30
• Catalog Number: SWDK 2030
• Company Name: I.V.T. MEDICAL LTD
• Labeler DUNS: 514996339
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-13
• Public Version: 3
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 76c244f1-f29a-40b2-90fd-4545fc74d83c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
MKY	System, Skin Closure	General, Plastic Surgery	878.4320	1

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
Package	17290111491303	GS1	Distribution Carton	20	In Commercial Distribution
Primary	07290111491306	GS1