FDA.reportPublic FDA data

CNAP® double finger cuff "medium"

Primary DI
09120073932822
Brand
CNAP® double finger cuff "medium"
Company
CNSystems Medizintechnik GmbH
Model
V4.8.X
Catalog number
20-FVMA-15520E
Device description
Unit; sensor with Extended Lifecycle (150h)
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082599000NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500ATCnsystem Medizintechnik AG2008-10-17DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120073932822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073932822091200739328229120073932822

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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
300526077
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
09120073933027CNAP® Monitor 500 HDV1.521-FHCN-155442024-07-10
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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