FDA.reportPublic FDA data

CNAP® Monitor 500 HD

Primary DI
09120073933027
Brand
CNAP® Monitor 500 HD
Company
CNSystems Medizintechnik GmbH
Model
V1.5
Catalog number
21-FHCN-15544
Device description
Main Unit;
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183521000CNAP MonitorCnsystems Medizintechnik GmbH2019-09-11DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120073933027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073933027091200739330279120073933027

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood pressure, noninvasiveA small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Degrees Celsius85 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4331672345633service@cnsystems.com

Regulatory Flags#

DUNS number
300526077
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120073932778CNAP® ArmslingV1.x.y20-FEMA-058052026-08-18
09120073932785CNAP® double finger cuff "small"V4.8.X20-FVMA-154202026-08-18
09120073932792CNAP® double finger cuff "medium"V4.8.X20-FVMA-155202026-08-18
09120073932808CNAP® double finger cuff "large"V4.8.X20-FVMA-156202026-08-18
09120073932815CNAP® double finger cuff "small"V4.8.X20-FVMA-15420E2026-08-18
09120073932822CNAP® double finger cuff "medium"V4.8.X20-FVMA-15520E2026-08-18
09120073932839CNAP® double finger cuff "large"V4.8.X20-FVMA-15620E2026-08-18
09120073932846CNAP® double finger cuff "small"V4.8.X20-FVMA-15420M2026-08-18
09120073932853CNAP® double finger cuff "medium"V4.8.X20-FVMA-15520M2026-08-18
09120073932860CNAP® double finger cuff "large"V4.8.X20-FVMA-15620M2026-08-18
09120073932877CNAP® double finger cuff "small"V4.8.X20-FVMA-15420U2026-08-18
09120073932884CNAP® double finger cuff "medium"V4.8.X20-FVMA-15520U2026-08-18
09120073932891CNAP® double finger cuff "large"V4.8.X20-FVMA-15620U2026-08-18
09120073933034CNAP® Armsling "small"V1.x.y20-FEMA-058062026-08-18
09120073933041TFC Armsling "small"V1.x.yTFC100392026-08-18
09120073931948Set of electrodesV1.016162018-10-04
09120073931962Set of electrodesV1.016162018-10-04
09120073932273TFC NBP Cuff SMALL-2023-10-18
09120073932280TFC NBP Cuff MEDIUM-2023-10-18
09120073932297TFC NBP Cuff LARGE-2023-10-18

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Primary DI, Brand, Company table
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00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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