FDA.reportPublic FDA data

GRAHAM FIELD

Primary DI
M368201BK1
Brand
GRAHAM FIELD
Company
GF HEALTH PRODUCTS, INC.
Model
201BK
Device description
DELUXE SPHYGMOMANOMETER, ADULT, BLACK
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K193259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193259000Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerLittle Doctor Electronic (Nantong)Co.,Ltd2020-07-02DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M369201BK2PackageHIBCC24In Commercial Distribution
M368201BK1PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
132016168
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368FR601EPCHBN04271LUMEXFR601EPCHBN-04272026-09-18
M368FR601EPCHBN96071LUMEXFR601EPCHBN-96072026-09-18
M368FR601EPCHNN04271LUMEXFR601EPCHNN-04272026-09-18
M368FR601EPCNBN04271LUMEXFR601EPCNBN-04272026-09-18
M368FR601EPCNNN04271LUMEXFR601EPCNNN-04272026-09-18
M368FR601EPCOBN04271LUMEXFR601EPCOBN-04272026-09-18
M368FR601EPCONN04271LUMEXFR601EPCONN-04272026-09-18
M368FR601EPNHBN04271LUMEXFR601EPNHBN-04272026-09-18
M368FR601EPNHNN04271LUMEXFR601EPNHNN-04272026-09-18
M368FR601EPNHNN86021LUMEXFR601EPNHNN-86022026-09-18
M368FR601EPNNBN04271LUMEXFR601EPNNBN-04272026-09-18
M368FR601EPNNBN86041LUMEXFR601EPNNBN-86042026-09-18
M368FR601EPNNNN03171LUMEXFR601EPNNNN-03172026-09-18
M368FR601EPNNNN04271LUMEXFR601EPNNNN-04272026-09-18
M368FR601EPNOBN04271LUMEXFR601EPNOBN-04272026-09-18
M368FR601EPNONN04271LUMEXFR601EPNONN-04272026-09-18
M368FR601EPNONN13111LUMEXFR601EPNONN-13112026-09-18
M368FR601EUCHBN04271LUMEXFR601EUCHBN-04272026-09-18
M368FR601EUCHNN04271LUMEXFR601EUCHNN-04272026-09-18
M368IN601EPCHBNCOM1INTENSAIN601EPCHBN-COM2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102159Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102166Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102173Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102197Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102203Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102210Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782101459Prosphyg™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
00634782102180Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
06975185470358LightningWenzhou Kangshun Medical Devices CO.,LTDDXQ2026-08-08
06971996170005MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170012MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170029MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170036MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170043MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170050MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170067MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170074MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170081MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170098MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170104MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170111MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170128MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170135MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170142MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170159MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170166MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170173MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170180MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170197MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170203MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07