FDA.reportPublic FDA data

Blood Pressure Meter

Primary DI
06972243188255
Brand
Blood Pressure Meter
Company
Wenzhou Renhua Instruments Co.,Ltd
Model
Model Max0202 (Blue, Pink or Black cuff)
Device description
The Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include additional stethoscope. It is conjunction with Stethoscope when use.
Published
2019-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190902000RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with StethoscopeWenzhou Renhua Instruments Co., Ltd.2019-05-22DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972243188255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972243188255069722431882556972243188255

GMDN Terms#

Term, Definition table
TermDefinition
Aneroid manual sphygmomanometerA device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541055663
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972243188118SINGLE HEAD STETHOSCOPERH30012020-02-27
06972243188125DUAL HEAD STETHOSCOPERH30022020-02-27
06972243188132RAPPAPORT STETHOSCOPERH30032020-02-27
06972243188163STAINLESS STEEL STETHOSCOPERH30062020-02-27
06972243188224LUXURY STETHOSCOPERH30122020-02-27
06972243188019Blood Pressure MeterModel Max02 (Blue, Pink or Black cuff)2019-07-12
06972243188149Blood Pressure MeterModel Max0201 (Blue, Pink or Black cuff)2019-07-12
06972243188279Blood Pressure MeterModel Max0203 (Blue, Pink or Black cuff)2019-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973438504CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
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