FloSure 100520

GUDID 14260160094292

simex FloSure Ventilation Patch for the vacuum wound drainage

SIMEX Medizintechnik GmbH

Synthetic polymer semi-permeable film dressing, adhesive, sterile Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive

• Primary Device ID: 14260160094292
• NIH Device Record Key: 1e9c1dca-c7f5-4f56-8214-55fd25a108f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloSure
• Version Model Number: FloSure Ventilation Patch
• Catalog Number: 100520
• Company DUNS: 344498415
• Company Name: SIMEX Medizintechnik GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de
• Phone: +49742092040
• Email: info@simexmed.de

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260160094295 [Primary]
GS1	14260160094292 [Package]; Contains: 04260160094295; Package: white paperboard box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150459

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by SIMEX Medizintechnik GmbH

• 04052262385551 - simex: 2018-07-06 SIMEX300 NPWT-System, green
• 04052262385568 - simex: 2018-07-06 SIMEX200 NPWT-System, green
• 04052262385957 - simex: 2018-07-06 SIMEX cuff M suction
• 04052262385964 - simex: 2018-07-06 SIMEX cuff S suction
• 14260160094292 - FloSure: 2018-07-06simex FloSure Ventilation Patch for the vacuum wound drainage
• 14260160094292 - FloSure: 2018-07-06 simex FloSure Ventilation Patch for the vacuum wound drainage
• 04052262076725 - simex: 2018-04-12 Suction tube, 50cm, Luer, sterile
• 04052262413513 - simex: 2018-04-12 Suction tube, sterile, CH21, 180cm with clamp, funnel and luer connector