FDA.report

EDGE System™ Electrodes with QUIK-COMBO Connector

Primary DI
00721902195075
Brand
EDGE System™ Electrodes with QUIK-COMBO Connector
Company
PHYSIO-CONTROL, INC.
Model
11996
Catalog number
11996-000091
Device description
ELECTRODE-EDGE,ADULT,QCSTD, WORLDWIDE
Published
2014-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20721902195079PackageGS110In Commercial Distribution
40721902195073PackageGS150In Commercial Distribution
00721902195075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2072190219507920721902195079
4072190219507340721902195073
00721902195075007219021950757219021950750721902195075

GMDN Terms

TermDefinition
External defibrillator electrode, adult, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)442-1142rs.seacustomersupport@physio-control.com

Regulatory Flags

DUNS number
009251992
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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07613327691344LIFEPAK 35 Monitor/Defibrillator9633596335-000000U2025-12-18
07613327691351LIFEPAK 35 Monitor/Defibrillator9633596335-000001U2025-12-18
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00883873760048SHIP KIT, POWER SUPPLY, LP354133541335-0000032025-09-26
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FT1123011230-0000282025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGAN1123011230-0000272025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP351123011230-0000262025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP351123011230-0000252025-09-26
00883873760475CHARGER, BATTERY, LP351114011140-0001322025-09-26
00883873760482BATTERY, LI-ION, WITH IFU, LP351133511335-0000092025-09-26
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