simex 100687-3

GUDID 04052262385551

SIMEX300 NPWT-System, green

SIMEX Medizintechnik GmbH

Multi-purpose low-vacuum suction system

• Primary Device ID: 04052262385551
• NIH Device Record Key: 805a9bbd-9c8b-4e16-8d73-df69a0c62781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simex
• Version Model Number: SIMEX300
• Catalog Number: 100687-3
• Company DUNS: 344498415
• Company Name: SIMEX Medizintechnik GmbH
• 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: 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: +49742092040
• Email: info@simexmed.de

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052262385551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113291

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: 2016-09-12

On-Brand Devices [simex]

• 04052262413513: Suction tube, sterile, CH21, 180cm with clamp, funnel and luer connector
• 04052262385964: SIMEX cuff S suction
• 04052262385957: SIMEX cuff M suction
• 04052262385568: SIMEX200 NPWT-System, green
• 04052262385551: SIMEX300 NPWT-System, green
• 04052262076725: Suction tube, 50cm, Luer, sterile