Box - 600 ml. SeromaSet

GUDID 05700002169747

A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Innoventa Medica ApS

Closed-wound/centesis drainage receptacle

• Primary Device ID: 05700002169747
• NIH Device Record Key: f3277908-b4cf-41e8-932c-49d084619930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Box - 600 ml. SeromaSet
• Version Model Number: 1061
• Company DUNS: 311706696
• Company Name: Innoventa Medica ApS
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002169716 [Unit of Use]
GS1	05700002169747 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by Innoventa Medica ApS

• 05700002169730 - Box - 400 ml. SeromaSet: 2024-11-11 A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent
• 05700002169747 - Box - 600 ml. SeromaSet: 2024-11-11A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
• 05700002169747 - Box - 600 ml. SeromaSet: 2024-11-11 A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent