FDA.reportPublic FDA data

DIXIE

Primary DI
10697038425027
Brand
DIXIE
Company
HONSUN (NANTONG) CO.,LTD
Model
HS-50D
Published
2017-11-22
Public version status
Update
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
K092245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092245000ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100Honsun (Nantong) Co., Ltd.2009-10-28DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10697038425027PrimaryGS10
00697038425020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069703842502710697038425027
00697038425020006970384250206970384250200697038425020

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
543364560
Device count
25
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970384252163SCIANAres6A2026-07-30
16970384252160SCIANAres6A2026-07-30
26970384252167SCIANAres6A2026-07-30
06970384254518SCIANLD-562U2024-09-09
06970384254440SCIANLD-5622024-09-05
16970384250227HONSUNHS-30J2022-03-31
06970384250220HONSUNHS-30J2022-03-31
16970384254515/LD-562U2024-09-09
16970384250180SCIANLD5212022-03-31
16970384250616SCIANLD-5202022-03-31
16970384250623SCIANLD-5272022-03-31
16970384250630SCIANLD-562S2022-03-31
16970384250944SCIANLD-566S2022-03-31
06970384250183SCIANLD5212022-03-31
06970384250619SCIANLD-5202022-03-31
06970384250626SCIANLD-5272022-03-31
06970384250633SCIANLD-562S2022-03-31
06970384250947SCIANLD-566S2022-03-31
16970384250173SCIANLD5332022-03-31
16970384250210SCIANLD-753S2022-03-31

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