FDA.reportPublic FDA data

FUKUDA DENSHI

Primary DI
04538612100635
Brand
FUKUDA DENSHI
Company
FUKUDA DENSHI CO.,LTD.
Model
SD-2G
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04538612100635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04538612100635045386121006354538612100635

GMDN Terms#

Term, Definition table
TermDefinition
Data storage cardA small electronic device designed to connect to a dedicated port of a computer, typically called a card slot, to download or upload saved data. Commonly known as a memory card or PC card, it is made of metal and plastic materials and typically has flat metal segmented contact points at one end to connect to computerized devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690671011
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04538612151569FUKUDA DENSHISD-1G5202010502026-07-17
04538612161049FUKUDA DENSHIFCF-1285204004702026-07-17
04538612209543FUKUDA DENSHIFCF-10005592005692026-07-17
04538612226113FUKUDA DENSHIFCF-16GA5502076402026-07-17
04538612226922FUKUDA DENSHISD-8G5502666702026-07-17
04538612228070FUKUDA DENSHIFSD-8GA5510865002026-07-17
04538612230370FUKUDA DENSHICJO-31RS55513798002026-07-17
04538612230387FUKUDA DENSHIFSD-2G5513823802026-07-17
04538612054181FUKUDA DENSHIABT-720D2026-04-23
04538612914256FUKUDA DENSHIABT-810D2023-01-06
04538612914263FUKUDA DENSHIOAT-03A2023-01-06
04538612061912FUKUDA DENSHIABT-X1C2026-04-23
04538612916359FUKUDA DENSHIDS-X1M2026-04-23
04538612916373FUKUDA DENSHIDS-X1N2026-04-23
04538612916410FUKUDA DENSHIOAT-X1A2026-04-23
04538612230554FUKUDA DENSHIOAT-07A0.752026-04-02
04538612916502FUKUDA DENSHIOAO-125A2026-04-02
04538612916540FUKUDA DENSHICJO-32RS0.12026-04-02
04538612228483FUKUDA DENSHIFCS-64G5511207902026-03-06
04538612916328FUKUDA DENSHILXN-10002025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01