NEWERA I Wound Drainage Pump 3000700-IHT

GUDID 87181048900534

The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to

Meditop B.V.

Negative-pressure wound therapy system, line-powered

• Primary Device ID: 87181048900534
• NIH Device Record Key: b55a5ddf-de26-4100-9579-ff288c4ca49c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEWERA I Wound Drainage Pump
• Version Model Number: XL
• Catalog Number: 3000700-IHT
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	87181048900534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082311

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-09

On-Brand Devices [NEWERA I Wound Drainage Pump]

• 87181048900534: The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou
• 08718104890053: The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou