ExtriCARE

Basic Information

• Brand Name: ExtriCARE
• Primary DI: 04897089070217
• Version / Model: ST403-0001
• Catalog Number: EC-DRAPE
• Company Name: ALLEVA MEDICAL LIMITED
• Labeler DUNS: 669361099
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-28
• Public Version: 1
• Public Version Date: 2024-01-05
• Public Version Status: New
• Public Device Record Key: 6bb77d49-643f-4d94-85de-d94628f93e5a

Device Description

Negative Pressure Wound Therapy Drape - 33.5x32cm

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: 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: Yes
• Sterilization Methods: Ethylene Oxide

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
47405	Negative-pressure wound therapy system drape	A sheet of plastic material designed to be placed over a wound dressing (e.g. open-cell foam or medicated gauze) to create a complete occlusion over and around a wound during negative pressure wound therapy (NPWT). This film dressing is typically vapour permeable, waterproof, and has an adhesive backing or edges applied against the wound dressing and surrounding healthy skin to create an airtight seal; it may be impregnated/coated with a gel (e.g., silicone) to minimize risk of trauma upon removal. It has a central opening, or an opening is made in or under it, to enable placement of the drain allowing negative pressure to reach the wound through the dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14897089070214	GS1	Case	50	In Commercial Distribution
Primary	04897089070217	GS1

Premarket Submissions

Submission Number	Supplement Number
K140634	000