Device
AESCULON comprehensive cardiovascular monitor for non-invasive hemodynamic measurement
Manufacturer
Osypka Medical GmbH
Osypka Medical GmbH
Model: AESCULON
DI: 04260451441180
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
AESCULON comprehensive cardiovascular monitor for non-invasive hemodynamic measurement
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a20a2a7c-9342-4472-a1b1-9842337db6e0
Distribution Status:
In Commercial Distribution
DUNS Number:
317157048
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04260451441180
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17496
Name: Impedance cardiac output unit
Definition:
A device used to quantify cardiac output from measurements of the thoracic impedance changes associated with cardiac activity. It typically consists of electrodes appropriate to measure the thoracic impedance and an electronic unit that processes the data and displays the cardiac output values. This device only measures in real time and does not record data.
FDA Product Codes
DSB
Plethysmograph, Impedance
Premarket Submissions
Submission Number:
K081035
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-20
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
60
Storage Handling - Storage Handling Type:
Storage Environment Temperature