CARDIOVIT® AT-2 plus 3.911013

GUDID 07613365000016

The CARDIOVIT® AT-2 plus is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings.

Schiller AG

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• Primary Device ID: 07613365000016
• NIH Device Record Key: bca49496-39b4-49a0-a72f-cfd56468d2bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOVIT® AT-2 plus
• Version Model Number: 3.911013
• Catalog Number: 3.911013
• Company DUNS: 480868538
• Company Name: Schiller AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365000016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953396

FDA Product Code

• DPS: Electrocardiograph

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: 2020-02-17
• Device Publish Date: 2016-09-18

On-Brand Devices [CARDIOVIT® AT-2 plus]

• 07613365000931: The CARDIOVIT® AT-2 plus is a 12-lead ECG device used for the recording, analysis and evaluatio
• 07613365000016: The CARDIOVIT® AT-2 plus is a 12-lead ECG device used for the recording, analysis and evaluatio