CC1 Wound Drainage pump 3000700-CCT

GUDID 08718104890459

The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as the device may promote wound healing.

Meditop B.V.

Negative-pressure wound therapy system, line-powered

• Primary Device ID: 08718104890459
• NIH Device Record Key: ec888b06-8aee-487a-a199-7d0025133361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CC1 Wound Drainage pump
• Version Model Number: XL
• Catalog Number: 3000700-CCT
• Company DUNS: 387209518
• Company Name: Meditop B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl
• Phone: +31348566100
• Email: info@meditop.nl

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08718104890459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082311

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: 2020-12-18
• Device Publish Date: 2020-12-10

Devices Manufactured by Meditop B.V.

• 08718104890008 - Exsudex Wound Drainage pump: 2021-11-23 The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application
• 08718104890015 - Exsudex Wound Drainage Pump: 2021-11-23 The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application
• 08718104890473 - Exsudex disposable canister: 2021-03-08 The Exsudex® Disposable Canister, commercially labelled as CCT 1 Disposable Canister, has the following features and is only to
• 08718104890480 - Exsudex disposable canister: 2021-03-08 The Exsudex® Disposable Canister, commercially labelled as CCT Mini Disposable Canister, has the following features and is only
• 08718104890459 - CC1 Wound Drainage pump: 2020-12-18The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as the device may promote wound healing.
• 08718104890459 - CC1 Wound Drainage pump: 2020-12-18 The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application
• 08718104890466 - CCT Mini Wound Drainage pump: 2020-12-18 The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application
• 08718104890084 - Exsudex disposable canister: 2020-05-06 The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only t
• 08718104890091 - Exsudex disposable canister: 2020-05-06 The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only t