SEER 1000 PC App 2067634-055

GUDID 04250903201196

The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).

getemed Medizin- und Informationstechnik AG

Electrocardiographic ambulatory recorder

• Primary Device ID: 04250903201196
• NIH Device Record Key: a5d9d5dc-933f-4d8b-bbdb-b99fb9fc19b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEER 1000 PC App
• Version Model Number: V1.0SP03
• Catalog Number: 2067634-055
• Company DUNS: 331682898
• Company Name: getemed Medizin- und Informationstechnik AG
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49332839420
• Email: info@getemed.de

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903201196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130785

FDA Product Code

• MWJ: Electrocardiograph,Ambulatory(Without Analysis)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-21

Devices Manufactured by getemed Medizin- und Informationstechnik AG

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• 04250903202643 - SEER 1000: 2023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202650 - SEER 1000: 2023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202520 - CardioDay: 2023-07-31 The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulator
• 04250903200724 - SEER 1000: 2021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903200731 - SEER 1000: 2021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903200748 - SEER 1000: 2021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202469 - CardioDay: 2021-06-03 The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulator