ECG Cables and Leadsets

Primary DI
20884838006793
Brand
ECG Cables and Leadsets
Company
Philips Medical Systems Hsg
Model
Preattached leadwire electrode, Square
Catalog number
989803100551
Device description
"Preattached leadwire electrode, Square Radiolucent carbon AAMI color 45cm/18"" leadwires with 1.5mm/.060"" safety socket square 22cm x 22cm cloth backing with Ag/Cl sensor, 3/pouch, 300/case."
Published
2017-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRYMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900682000PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODEContour Electrodes, Inc.1990-07-31DRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884838006793PrimaryGS10
10884838006796Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088483800679320884838006793
1088483800679610884838006796

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790605856
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00884838013377ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI, TELE9898031718212016-10-13
00884838013384ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, TELE9898031718312016-09-27
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20884838013494ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE9898031720312016-10-12
00884838013421ECG ElectrodesCBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE9898031718712016-11-22
00884838013445ECG ElectrodesCBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE9898031719112016-11-29
00884838013452ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC, TELE9898031719312016-10-13
00884838013469ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE9898031719512016-10-13
00884838013476ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC, TELE9898031719612016-11-01
00884838013483ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE9898031719712016-12-07

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