My Medic

Primary DI
00850029189787
Brand
My Medic
Company
My Medic
Model
Max0203
Catalog number
Blue
Device description
A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb ( for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid mano bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transm lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may b on a table, or hand held(portable); blood pressure measurement is taken in conjunction with a stethoscope.
Published
2021-03-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff
LDEStethoscope, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2
LDEStethoscope, ManualCardiovascular1

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
00850029189787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029189787008500291897878500291897870850029189787

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
079772888
Device count
1
Kit
true
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
00850029189916My MedicBP0001BPCUFFBLK2021-07-07
00850029189763My MedicMax0203pink2021-03-10
00850029189770My MedicMax02032021-01-16
08500139032030My MedicMax0203pink2021-03-10
08500139037998My MedicMax0203Blue2021-03-10
00850013903771My MedicMax02032021-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00634782102173Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102197Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102203Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102210Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782101459Prosphyg™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
00634782101848Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102098Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102104Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102111Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102128Adsoft™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102180Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
06975185470358LightningWenzhou Kangshun Medical Devices CO.,LTDDXQ2026-08-08
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