IEM GmbH

GUDID 04041346102054

Hypertension Management Software

IEM GmbH

Medical equipment clinical data interfacing software

• Primary Device ID: 04041346102054
• NIH Device Record Key: 3de2dccf-793c-442d-879b-ee6d9e23f5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IEM GmbH
• Version Model Number: HMS CS 6.1.3 Medtronic 1.0.0
• Company DUNS: 344030150
• Company Name: IEM 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: false
• Manufacturing Date: true
• 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	04041346102054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153557

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [IEM GmbH]

• 04041346100876: Hypertension Management Software
• 04041346102054: Hypertension Management Software
• 04041346102153: Hypertension Management Software Version 6
• 04041346102207: Hypertension Management Software Version 6