FDA.reportPublic FDA data

TONOPORT VI

Primary DI
04260671371021
Brand
TONOPORT VI
Company
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
Model
2001589-202
Published
2024-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K170966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170966000TONOPORT VIPar Medizintechnik GmbH & Co. KG2017-06-14DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260671371021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260671371021042606713710214260671371021

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry.
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49302350700info@par-berlin.com

Regulatory Flags#

DUNS number
324233626
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260671372561blood pressure cuff, Size M, for digital devicesA2534-m2020-12-21
04260671372578blood pressure cuff, Size L, for digital devicesA2534-l2020-12-21
04260671372585blood pressure cuff, Size XL, for digital devicesA2534-xl2020-12-21
04260671372592blood pressure cuff, Size XXL, for digital devicesA2534-xxl2020-12-21
04260671372547blood pressure cuff, Size XS, for digital devicesA2534-xs2020-12-21
04260671372554blood pressure cuff, Size S, for digital devicesA2534-s2020-12-21
04260671372004TONOPORT BP Cuff for Adults, Small2001589-2112020-03-06
04260671372011TONOPORT BP Cuff for Adults, Standard2001589-2122020-03-06
04260671372028TONOPORT BP Cuff for Adults, Large2001589-2132020-03-06
04260671372035TONOPORT BP Cuff for Adults, Extra-large2001589-2142020-03-06
04260671372202TONOPORT BP Single-Use Cuff for Adults, Small2001589-2322020-03-06
04260671372219TONOPORT BP Single-Use Cuff for Adults, Standard2001589-2332020-03-06
04260671372226TONOPORT BP Single-Use Cuff for Adults, Large2001589-2342020-03-06
04260671372233TONOPORT BP Single-Use Cuff for Adults, Extra-large2001589-2352020-03-06
00742832731522TONOPORT BP CUFF ADULT SMALL2001589-2112016-06-13
00742832731539TONOPORT BP CUFF ADULT STANDARD2001589-2122016-06-13
00742832731546TONOPORT BP CUFF ADULT LARGE2001589-2132016-06-13
00742832731553TONOPORT BP CUFF ADULT EXTRA LARGE2001589-2142016-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
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06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27