FDA.reportPublic FDA data

Osypka Medical

Primary DI
04260451441180
Brand
Osypka Medical
Company
Osypka Medical GmbH
Model
AESCULON
Device description
AESCULON comprehensive cardiovascular monitor for non-invasive hemodynamic measurement
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081035000AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2Osypka Medical, Inc.2008-05-30DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260451441180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260451441180042604514411804260451441180

GMDN Terms#

Term, Definition table
TermDefinition
Impedance cardiac output unitA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
317157048
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260451441043CARDIOTRONICICON2021-04-30
04260451441050CARDIOTRONIC PACE 10120042021-04-30
04260451441067CARDIOTRONIC PACE 20320032021-04-30
04260451441173Osypka MedicalPSA 2002021-04-30
04260451441012CARDIOTRONIC PACE 10120012016-09-13
04260451441029CARDIOTRONIC PACE 20320022016-09-13

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