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 Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel
Primary Device ID07613365003772
NIH Device Record Keyf2725272-4243-4757-b108-ffa851b452c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioPulse Prime
Version Model Number3.912422
Catalog Number98310
Company DUNS480868538
Company NameSchiller AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107613365003772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-15
Device Publish Date2021-11-05

Devices Manufactured by Schiller AG

07613365002201 - Schiller ECG D-SUB C 3.5 x10 IEC2023-10-17 10-wire patient cable IEC, clip-type, 3.5m
07613365002232 - Schiller ECG D-SUB B 2.0 x10 IEC2023-10-17 10-wire patient cable IEC, banana plug, 2m
07613365002775 - CARDIOVIT AT-1802023-10-17 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 IEC2023-10-17 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 IEC2023-10-17 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 cable2023-10-05 IBP LP 3.0 PVB CC
07613365003093 - Schiller IBP transducer connecting cable2023-10-05 IBP LP 3.7 OHMEDA CC
07613365003499 - Schiller IBP transducer connecting cable2023-10-05 IBP LP 4.5 Transpac IV CC
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.