FDA.reportPublic FDA data

Caremate

Primary DI
06971329980967
Brand
Caremate
Company
CAREMATE MEDICAL DEVICE CO., LTD
Model
CM-PBPM-1
Published
2026-04-24
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
K211084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211084000Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd.2021-10-19DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971329980967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971329980967069713299809676971329980967

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
421090818
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971329980608CaremateCM-BPM2026-04-24
06971329980936CaremateCM-BPM-S2026-04-24
06971329980943CaremateCM-BPM-D2026-04-24
06971329980950CaremateCM-BPM-R2026-04-24
06971329980974CaremateCM-PBPM-22026-04-24
06971329980981CaremateCM-PBPM-32026-04-24
06971329980998CaremateCM-PBPM-C2026-04-24
06971329980271LOTFANCYCM-BPM for Adult2020-05-15
06971329980295LOTFANCYCM-BPM for LA2020-05-15
06971329980301LOTFANCYCM-BPM for Thigh2020-05-15
06971329980318LOTFANCYCM-BPM for Adult-12020-05-15
06971329980325LOTFANCYCM-BPM for Adult-22020-05-15
06971329980332LOTFANCYCM-BPM for Comber2020-05-15
06971329980288LOTFANCYCM-BPM for Child2020-05-12
06971329980349LOTFANCYCM-BPM for Adult-32020-05-12
06971329980356ClairreSPM01002020-05-01
06971329980172EVERDIXIE422208B2018-08-28
06971329980189EVERDIXIE1434062018-08-28
06971329980196EVERDIXIE1434072018-08-28
06971329980202EVERDIXIE143401BK2018-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782101725Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-03-30
06940211627693MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627709MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627969MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628010MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628027MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628034MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628041MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628058MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628065MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628089MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628096MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628102MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628126MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628133MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628140MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628157MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628164MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628188MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628263MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628317MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628515MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628522MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628539MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628546MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628584MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628669MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628676MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31