CardioPulse Prime 98310

GUDID 07613365003772

The CardioPulse Prime is a 12-lead ECG device intended to be used by trained medical professionals in healthcare facilities for cardiological diagnosis in adult and paediatric patients.

Schiller AG

Electrocardiograph, professional, multichannel

• Primary Device ID: 07613365003772
• NIH Device Record Key: f2725272-4243-4757-b108-ffa851b452c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioPulse Prime
• Version Model Number: 3.912422
• Catalog Number: 98310
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365003772 [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: 2021-11-15
• Device Publish Date: 2021-11-05

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: 2023-10-17 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