FDA.reportPublic FDA data

ECG Cables and Leadsets

Primary DI
20884838006762
Brand
ECG Cables and Leadsets
Company
Philips Medical Systems Hsg
Model
Preattached Leadwire electrode, Medium
Catalog number
989803100511
Device description
"Preattached Leadwire electrode, Medium Radiolucent carbon AAMI color 45cm/18"" leadwires with 1.5mm/.060"" safety socket rectangular 33cm x 22cm cloth backingwith Ag/AgCl sensor, 3/pouch, 300/case."
Published
2016-12-27
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
20884838006762PrimaryGS10
10884838006765Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088483800676220884838006762
1088483800676510884838006765

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

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