My Medic

Primary DI
00850029189916
Brand
My Medic
Company
My Medic
Model
BP0001
Catalog number
BPCUFFBLK
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
2021-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00850029189916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029189916008500291899168500291899160850029189916

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

Contacts#

Phone, Email table
PhoneEmail
866-377-8243ouch@mymedic.com

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
00850029189763My MedicMax0203pink2021-03-10
00850029189770My MedicMax02032021-01-16
00850029189787My MedicMax0203Blue2021-03-10
08500139032030My MedicMax0203pink2021-03-10
08500139037998My MedicMax0203Blue2021-03-10
00850013903771My MedicMax02032021-01-16

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Primary DI, Brand, Company table
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