FDA.reportPublic FDA data

MR Patient Care Long Extra Wide ECG 2.0 Cable IEC

Primary DI
00884838102439
Brand
MR Patient Care Long Extra Wide ECG 2.0 Cable IEC
Company
Philips Ds North America LLC
Model
Long Extra Wide ECG 2.0 Cable IEC
Catalog number
989803185481
Device description
IEC version of the 989803176381 ECG cable
Published
2021-05-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838102439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838102439008848381024398848381024390884838102439

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
Storage Environment Atmospheric Pressure57 KiloPascal102 KiloPascal
Storage Environment Atmospheric Pressure429 Millimeter of Mercury765 Millimeter of Mercury
Storage Environment Atmospheric Pressure570 millibar1020 millibar
Storage Environment Humidity5 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
013649151
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838100114Invivo4535-302-233312020-04-17
00884838066991Invivo7840112016-09-23
00884838072558Invivo989603205282016-09-23
00884838072565Invivo989603203012016-09-23
00884838072572Invivo989603203022016-09-23
00884838073456Invivo989603208782016-09-23
00884838073463Invivo989603208792016-09-23
00884838081543Invivo7840122016-09-23
00884838082885Invivo989603210042017-07-28
00884838083592Invivo7840012016-09-23
00884838098459PhilipsdS FLEX-S 1.5T4598017299712021-06-11
00884838080997GE16ch Shoulder Coil4598008700112016-09-23
00884838081734InvivoBiopsy Grid (User-sterilized)4598015086412016-09-23
00884838107977MRI CoilsdS Microscopy 23mm, Ingenia 1.5T4598017950422021-10-28
00884838065390InvivoSENSE MSK M 8ch 1.5T4535303103522016-09-23
00884838072923KITS (Disposables)Needle Block, 8G9896032034532016-09-23
00884838072930KITS (Disposables)Needle Block, 12G9896032034632016-09-23
00884838072961KITS (Disposables)Needle Block, 18G9896032034832016-09-23
00884838072992KITS (Disposables)MRI Needle Sleeve 16G9896032043132016-09-23
00884838073067Invivo KITS (Disposables)Pillar Immobilization Plate BBC9896032035832016-09-23

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