FDA.reportPublic FDA data

Generic

Primary DI
00810025360030
Brand
Generic
Company
MAGNUM MEDICAL, INC.
Model
Adult
Catalog number
100-0342
Device description
Adult Aneroid (Blood pressure cuff with tubing and gauge - Various Colors) in a zipper bag.
Published
2019-09-26
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
00810025360030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810025360030008100253600308100253600300810025360030

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
603065293
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810025360184Magnum Medical05-20662023-08-15
00810025360191Magnum Medical05-20752023-08-15
00810025360207Magnum Medical05-21002023-08-15
00810025360214Magnum Medical05-21202023-08-15
00810025360221Magnum Medical05-23902023-08-15
00810025360238Magnum Medical05-23912023-08-15
00810025360252Magnum Medical05-11002023-08-15
10810025360181Magnum Medical05-20662023-08-15
20810025360195Magnum Medical05-20752023-08-15
10810025360204Magnum Medical05-21002023-08-15
10810025360211Magnum Medical05-21202023-08-15
20810025360225Magnum Medical05-23902023-08-15
20810025360232Magnum Medical05-23912023-08-15
20810025360256Magnum Medical05-11002023-08-15
00810025360245Magnum Medical05-20552023-08-10
10810025360242Magnum Medical05-20552023-08-10
00810025360092Magnum Medical20-010-12022-08-26
00810025360085Magnum Medical20-6-014B-TC/OM2022-07-29
00196852500703Magnum Medical20-6-014B-TC/OM2022-07-29
00810025360023GenericAdult100-0341-0022019-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXQ2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXQ2026-07-20
06931973438504CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438511CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438528CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973454689CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456737CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456744CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456751CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456768CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456775CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456782CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456799CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456805CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456812CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456829CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456836CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456843CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456850CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456867CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456874CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456881CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456898CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456904CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456911CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456928CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456935CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456942CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456959CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456966CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09