FDA.reportPublic FDA data

PARAMED

Primary DI
00856324008167
Brand
PARAMED
Company
SILEX GLOBAL LLC
Model
CM-BPM-S
Device description
Blood Pressure Cuff Manual. Basic Black
Published
2019-05-13
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
K090014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090014000CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPECaremate Medical Device Co., Ltd.2009-04-09DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856324008167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856324008167008563240081678563240081670856324008167

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
081135914
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856324008112ParamedRH30092022-12-23
00856324008129ParamedRH30122022-12-23
00856324008440ParamedCM-41362022-12-23
00856324008136ParamedThermometer DT0012018-05-18
00856324008723PARAMEDDigital Blood Pressure Monitor (Upper-arm) B152021-10-28
00856324008730PARAMEDDigital Blood Pressure Monitor (Upper-arm) B22S2021-10-28
00856324008693PARAMEDDigital Blood Pressure Monitor (Upper-arm) B222021-09-08
00856324008181paramedInfrared ear/forehead thermometer YK-IRT12020-06-19
00856324008297paramedInfrared ear/forehead thermometer PG-IRT16032020-06-19
00856324008488paramedWrist Blood Pressure monitor PG-800A372020-06-19
00856324008310PARAMEDPG-800A112019-09-02
00856324008426PARAMEDB512019-09-02
00856324008099ParamedDigital Blood Pressure Monitor (Upper-arm) B222018-05-18
00856324008105ParamedWrist Blood Pressure monitor PG-800A122018-05-18
00856324008327PARAMEDMAX0201 2019-06-14
00856324008334PARAMEDMAX0201 2019-06-14
00856324008341PARAMEDMAX0201 2019-06-14
00856324008358PARAMEDMAX022019-06-14
00856324008365PARAMEDMAX022019-06-14
00856324008372PARAMEDMAX022019-06-14

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