11141-000100

GUDID 00883873793497

LP1000 ASSEMBLY BATTERY REPLACEMENT KIT

PHYSIO-CONTROL, INC.

Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery Primary battery
Primary Device ID00883873793497
NIH Device Record Key67df0652-e159-4375-8b50-d323a3a81af2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11141
Catalog Number11141-000100
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873793497 [Primary]
GS100885074503592 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-10
Device Publish Date2020-12-02

Devices Manufactured by PHYSIO-CONTROL, INC.

50883873784933 - EDGE SYSTEM2023-07-06 EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
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 - NA2020-12-10LP1000 ASSEMBLY BATTERY REPLACEMENT KIT
00883873793497 - NA2020-12-10 LP1000 ASSEMBLY BATTERY REPLACEMENT KIT

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