SEER 1000 2067634-063

GUDID 04250903202650

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.

getemed Medizin- und Informationstechnik AG

Electrocardiographic ambulatory recorder

• Primary Device ID: 04250903202650
• NIH Device Record Key: cf062640-23b5-4939-a0dc-046430469c41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEER 1000
• Version Model Number: 7 day - Japanese
• Catalog Number: 2067634-063
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903202650 [Primary]

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [SEER 1000]

• 04250903200748: The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
• 04250903200731: The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
• 04250903200724: The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
• 04250903202650: The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
• 04250903202643: The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
• 04250903202636: The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000