FDA.report

Telemetry Accessories

Primary DI
00884838119147
Brand
Telemetry Accessories
Company
Philips Medizin Systeme Böblingen GmbH
Model
Telemetry Adapter 6L+SpO2
Catalog number
989803199071
Device description
Telemetry Adapter 6L+SpO2
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications

CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884838119147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838119147008848381191478848381191470884838119147

GMDN Terms

TermDefinition
Electrocardiographic lead set, reusableA 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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags

DUNS number
314101143
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
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
00884838117433NOUNDigiTrak XT Patient Cable Short9898031574812026-03-19
00884838113770MR Patient Care Adult SpO2 ClipAdult SpO2 Clip9898031665312026-03-16
00884838100978MR Patient Care Pediatric SpO2 ClipPediatric SpO2 Clip9898031665412026-03-16
00884838128880Patient Information Center iX4.68663892026-03-09
00884838129214Care Assist4.69898032215412026-03-09
00884838129221Care Assist4.69898032215312026-03-09
00884838117877MR Patient Care Pediatric SpO2 ClipPediatric SpO2 Clip9898031665412025-05-22
00884838117358patient lead wireStandard 10-lead Patient Cable IEC9898031849212026-03-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00884838119079Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119086Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119093Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119109Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119116Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119123Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119154Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119161Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119178Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838128880Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
04538612228483FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-03-06
00884838086678Masimo Sedline ModulePhilips Medizin Systeme Böblingen GmbHMHX2026-01-15
00199874152509MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
00199874432199MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
04538612916236FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916243FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916250FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916267FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612061905FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916281FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916304FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916403FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
00884838127074Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838107809Patient Monitor 6500Philips Medizin Systeme Böblingen GmbHMHX2025-11-11
06944413838420Patient MonitorEdan Instruments, Inc.MHX2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.MHX2025-09-05