FDA.reportPublic FDA data

FUKUDA DENSHI

Primary DI
04538612230332
Brand
FUKUDA DENSHI
Company
FUKUDA DENSHI CO.,LTD.
Model
OAO-1012A
Published
2023-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04538612230332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04538612230332045386122303324538612230332

GMDN Terms#

Term, Definition table
TermDefinition
Portable active medical device mountA device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

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
04538612061813FUKUDA DENSHICIO-13CTP-2.75513844702026-09-28
04538612061820FUKUDA DENSHICIO-13CTP-3.65513844802026-09-28
04538612230837FUKUDA DENSHIOAO-127A5514057702026-09-28
04538612230844FUKUDA DENSHIOAO-128A5514057802026-09-28
04538612916229FUKUDA DENSHICIO-13DIN3-2.7A5513848202026-09-28
04538612916632FUKUDA DENSHIBDS-2100M1514117202026-09-28
04538612916649FUKUDA DENSHIBDS-2100MR1514117302026-09-28
04538612916656FUKUDA DENSHIBDS-2100MRT1514117402026-09-28
04538612916663FUKUDA DENSHIBDS-2100N1514117502026-09-28
04538612916670FUKUDA DENSHIBDS-2100NR1514117602026-09-28
04538612916687FUKUDA DENSHIBDS-2100NRT1514117702026-09-28
04538612916694FUKUDA DENSHIHPD-1105514117802026-09-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953009567Carescape ONEGE Healthcare Finland OyDSI2026-10-04
04538612230387FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.DSI2026-07-17
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838119130Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119233Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119240Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSI2026-04-15
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-03-09
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838128729C6 Monitor A13, VerizonBRAEMAR MANUFACTURING, LLCDSI2025-10-06
00884838128736C6 Monitor A13, T MobileBRAEMAR MANUFACTURING, LLCDSI2025-10-06
06944413838406Patient Monitor Edan Instruments, Inc.DSI2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.DSI2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgDSI2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSI2024-11-27