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
10197344111565MEDLINEMEDLINE INDUSTRIES, INC.DXQ2026-05-21
M3681097001GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
10197344165346MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165377MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165391MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10326053121521Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121538Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121545Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121552Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121569Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121576Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121583Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121590Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121606Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121613Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121620Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121637Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121644Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121651Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121668Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121675Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121682Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121699Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121705Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10197344014514MEDLINEMEDLINE INDUSTRIES, INC.DXQ2024-09-02
10197344020645MedlineMEDLINE INDUSTRIES, INC.DXQ2024-03-27
M3682011GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
M368201BK1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
M368201BKC1GAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10