Avance® Solo

GUDID 07323190295982

Avance Solo Canister 50ml (4pcs)

Mölnlycke Health Care AB

Negative-pressure wound therapy system canister

• Primary Device ID: 07323190295982
• NIH Device Record Key: 3982ced6-a730-4e29-8e2f-82bc67576255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avance® Solo
• Version Model Number: 880050
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07323190295982 [Package]; Contains: 07323190295999; Package: [2 Units]; In Commercial Distribution
GS1	07323190295999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203369

FDA Product Code

• OMP: negative pressure wound therapy Powered suction pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-08
• Device Publish Date: 2022-01-31

On-Brand Devices [Avance® Solo]

• 07323190310746: Avance Solo Set with Dressing 10x35cm
• 07323190310715: Avance Solo Set with Dressing 10x30cm
• 07323190310685: Avance Solo Set with Dressing 10x20cm
• 07323190310654: Avance Solo Pump and Canister Set
• 07323190295982: Avance Solo Canister 50ml (4pcs)
• 07323190297801: Avance Solo Foam
• 07323190297627: Avance Solo Border Dressing 10x35 cm
• 07323190297740: Avance Solo Border Dressing 20x20 cm
• 07323190310531: Avance Solo Border Dressing 15x30 cm
• 07323190297689: Avance Solo Border Dressing 15x20 cm
• 07323190310449: Avance Solo Border Dressing 15x15 cm
• 07323190297573: Avance Solo Border Dressing 10x30 cm
• 07323190297771: Avance Solo Border Dressing 25x25 cm
• 07323190295944: Avance Solo Border Dressing 10x20 cm
• 07333350301347: Avance Solo Set with Dressing 10x20cm
• 07333350536480: Avance Solo Set with Dressing 10x35cm
• 07333350269326: Avance Solo Set with Dressing 10x30cm