FDA.reportPublic FDA data

Telemetry Accessories

Primary DI
20884838119776
Brand
Telemetry Accessories
Company
Philips Medizin Systeme Böblingen GmbH
Model
ECG 5 Lead Grabber IEC + SpO2, SPU, Tele
Catalog number
989803172151
Device description
ECG 5 Lead Grabber IEC + SpO2, SPU, Tele
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

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
20884838119776PrimaryGS10
00884838013520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483811977620884838119776
00884838013520008848380135208848380135200884838013520

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure10 KiloPascal108 KiloPascal
Storage Environment Humidity18 Percent (%) Relative Humidity78 Percent (%) Relative Humidity
Storage Environment Temperature12 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature53.6 Degrees Fahrenheit95 Degrees Fahrenheit

Regulatory Flags#

DUNS number
314101143
Device count
20
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26
00884838119130Telemetry AccessoriesECG Trunk Cable AAMI/IEC9898031722212026-05-26
00884838119147Telemetry AccessoriesTelemetry Adapter 6L+SpO29898031990712026-05-26
00884838119154Telemetry AccessoriesTelemetry Adapter SpO2-only9898031990812026-05-26
00884838119161Telemetry AccessoriesTelemetry Adapter 5L+SpO29898031990912026-05-26
00884838119178Telemetry AccessoriesTelemetry Adapter 3L+SpO29898031991012026-05-26
20884838119233Telemetry AccessoriesECG 5 lead Grabber, AAMI, SPU, Tele9898031720312026-05-26
20884838119240Telemetry AccessoriesECG 5 lead Grabber, IEC, SPU, Tele9898031721312026-05-26
00884838117396patient lead wire12L Leadset, Grabber, AAMI9898031801212026-05-21
00884838117402patient lead wire12L Leadset, Grabber, IEC9898031801312026-05-21
00884838117419patient lead wire12L Leadset, Snaps, AAMI9898031801412026-05-21
00884838117426patient lead wire12L Leadset, Snaps, IEC9898031801512026-05-21
20884838119769Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2,SPU,Tele9898031720512026-05-19
00884838107816Measurement Rack 6000Measurement Rack 60008673172026-05-19
00884838117372patient lead wireLong 10-lead Patient Cable IEC9898031849412026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
05903021560223PocketECG IV - Unified Arrhythmia Diagnostic SystemMEDICALGORITHMICS S ADSI2025-12-04
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
06944413838451Patient 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
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DSI2024-07-26
06944413815889Patient MonitorEdan Instruments, Inc.DSI2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.DSI2024-06-17