ECG Recording Paper

GUDID 07640187333008

Cardiovit AT-2, CS-200, AT-2plus, AT-170, AT-180

Diagramma AG

Electrocardiographic recording paper

• Primary Device ID: 07640187333008
• NIH Device Record Key: 2524cdd5-6c40-4427-be3f-81f47aff4726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Recording Paper
• Version Model Number: 2.157039
• Company DUNS: 487321176
• Company Name: Diagramma AG
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640187332995 [Primary]
GS1	07640187333008 [Package]; Contains: 07640187332995; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DSF: Recorder, Paper Chart

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-19
• Device Publish Date: 2023-01-17