HELMED HEL-1000

GUDID 04260186125003

Automated IFA Processor

Aesku.Systems GmbH & Co. KG

Multi-modality clinical specimen analysis system IVD

• Primary Device ID: 04260186125003
• NIH Device Record Key: f120866b-d832-4396-ab6b-a3ee44ae252d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELMED
• Version Model Number: HELMED IFA PROCESSOR KIT
• Catalog Number: HEL-1000
• Company DUNS: 341702675
• Company Name: Aesku.Systems GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260186125003 [Primary]
GS1	42601861205007 [Previous]

FDA Product Code

• JQW: Station, Pipetting And Diluting, For Clinical Use

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: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [HELMED]

• 42601861205007: Automated IFA Processor
• 04260186125003: Automated IFA Processor