Avance® Solo

Basic Information

• Brand Name: Avance® Solo
• Primary DI: 07323190236015
• Version / Model: 881520
• Company Name: Mölnlycke Health Care AB
• Labeler DUNS: 631770658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-31
• Public Version: 2
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: f8ef8c96-fa62-4d54-8d81-8c2d1a010cc6

Device Description

Avance Solo Border Dressing 15x20 cm

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
OMP	negative pressure wound therapy Powered suction pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47956	Negative-pressure wound therapy system dressing set	A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07323190297689	GS1		2	In Commercial Distribution
Primary	07323190236015	GS1
Package	07323190310500	GS1		2	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius