CARDIOVIT AT-180

GUDID 07613365002775

The CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis of cardiovascular diseases in adult and paediatric patients at rest.

Schiller AG

Electrocardiograph, professional, multichannel

• Primary Device ID: 07613365002775
• NIH Device Record Key: 323e74bd-dee3-41c0-a749-f9ebc2e64f64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOVIT AT-180
• Version Model Number: 3.920570
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365002775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183425

FDA Product Code

• DPS: Electrocardiograph

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: 2023-10-17
• Device Publish Date: 2023-10-09

Devices Manufactured by Schiller AG

• 07613365002201 - Schiller ECG D-SUB C 3.5 x10 IEC: 2023-10-17 10-wire patient cable IEC, clip-type, 3.5m
• 07613365002232 - Schiller ECG D-SUB B 2.0 x10 IEC: 2023-10-17 10-wire patient cable IEC, banana plug, 2m
• 07613365002775 - CARDIOVIT AT-180: 2023-10-17The CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis of cardiovascular diseases in adult and paediatric patients at rest.
• 07613365002775 - CARDIOVIT AT-180: 2023-10-17 The CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a license
• 07613365003291 - Schiller ECG EL-LT B 1.3/0.78 x4 IEC: 2023-10-17 Detachable single wires banana plug, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400142, 2.400141
• 07613365003802 - Schiller ECG EL-LT C 1.3/0.78 x4 IEC: 2023-10-17 Detachable single wires clip type, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400140, 2.400139
• 07613365002072 - Schiller IBP transducer connecting cable: 2023-10-05 IBP LP 3.0 PVB CC
• 07613365003093 - Schiller IBP transducer connecting cable: 2023-10-05 IBP LP 3.7 OHMEDA CC
• 07613365003499 - Schiller IBP transducer connecting cable: 2023-10-05 IBP LP 4.5 Transpac IV CC