FDA.reportPublic FDA data

NA

Primary DI
00884838011977
Brand
NA
Company
Philips Medizin Systeme Böblingen GmbH
Model
989803125871
Catalog number
989803125871
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838011977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838011977008848380119778848380119770884838011977

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a 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#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure10 KiloPascal108 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
314101143
Device count
1
DM exempt
false
Premarket exempt
true
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 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20192253019992KendallCardinal Health 200, LLCIKD2026-05-26
06946725550748APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725555316APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725571477APKAPK Technology Co.,Ltd.IKD2026-05-22
20653405017759CONMEDConmed CorporationIKD2026-03-24
20885380202480KendallCardinal Health 200, LLCIKD2026-03-20
20885380202497KendallCardinal Health 200, LLCIKD2026-03-20
B631ADX2GE61SureleadAuthentic MedicalIKD2026-03-13
B631DLSRPHP5L4F1SureLeadAuthentic MedicalIKD2026-03-13
B631EXTGE6PL8F1SureleadAuthentic MedicalIKD2026-03-13
B631TCGE2GE63M1SureleadAuthentic MedicalIKD2026-03-13
20885380208536CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
20885380208543CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
50885380208551CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
06946725509180APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509319APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509784APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509906APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513484APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513491APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513507APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513514APKAPK Technology Co.,Ltd.IKD2026-02-27
00850011306291High Density Tether 7.5mNEURALYNX, INC.IKD2026-02-19
00850011306307Tether Extension Cable Male-to-Male 3mNEURALYNX, INC.IKD2026-02-19
07613327688764N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-02-10
00849593025720AMCAdvantage Medical Electronics, LLCIKD2026-02-05
00849593025737AMCAdvantage Medical Electronics, LLCIKD2026-02-05
06941691983132Orantech Orantech Inc.IKD2026-01-29
06946725513200APKAPK Technology Co.,Ltd.IKD2026-01-23
06946725513217APKAPK Technology Co.,Ltd.IKD2026-01-23