FDA.reportPublic FDA data

N/A

Primary DI
06970366970023
Brand
N/A
Company
CARDICARE COMPANY LTD
Model
AS-P65
Device description
PALM ANEROID SPHYGMOMANOMETER
Published
2018-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K082542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082542000ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-ACardicare Company, Ltd.2008-09-17DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26970366970027PackageGS110In Commercial Distribution
06970366970023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697036697002726970366970027
06970366970023069703669700236970366970023

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.

Regulatory Flags#

DUNS number
528101293
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970366970085GRX MedicalBP-012019-11-25
06970366970092GRX MedicalBP-022019-11-25
06970366970078NONEAS-ND2019-09-25
26970366970072NONEAS-ND2019-09-25
06970366970061ASA TechmedAS-MC+SR KIT2019-07-04
06970366970030ASA TechmedAS-MC-PED2018-12-04
06970366970047ASA TechmedAS-MC-OB2018-12-04
06970366970054ASA TechmedAS-MC-TH2018-12-04
26970366970034ASA TechmedAS-MC-PED2018-12-04
26970366970041ASA TechmedAS-MC-OB2018-12-04
26970366970058ASA TechmedAS-MC-TH2018-12-04
06970366970016ASA TechmedAS-MC2018-05-14
26970366970010ASA TechmedAS-MC2018-05-14
26970366970027N/AAS-P652018-05-14

Other Devices Sharing Product Codes#

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