11103-000037

GUDID 00883873790687

ELECTRODES, 5-YEAR, LPCR2, LL

PHYSIO-CONTROL, INC.

Multifunction cardiac electrode, adult External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use
Primary Device ID00883873790687
NIH Device Record Key33245393-fc21-411a-b3c6-aaa7d431289e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11103
Catalog Number11103-000037
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 65 C (-22 TO 149 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873790687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-28
Device Publish Date2019-05-20

Devices Manufactured by PHYSIO-CONTROL, INC.

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50883873784940 - EDGE SYSTEM2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector
50883873784964 - EDGE SYSTEM2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System
00883873772676 - Emergency Response Kit2023-03-20 Emergency Response Kit
00883873824597 - Replacement Kit for CHARGE-PAK battery charger2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE
00883873824603 - CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE
00883873824610 - ELECTRODE ASSY-QUIK-COMBO2023-02-28 ELECTRODE ASSY-QUIK-COMBO QUIK-PAK,SET,WW
00883873793497 - NA2020-12-10 LP1000 ASSEMBLY BATTERY REPLACEMENT KIT
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