LIFEPAK 35 Monitor/Defibrillator 99335-000032U

GUDID 07613327673357

CPO,LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN

PHYSIO-CONTROL, INC.

Physiologic-monitoring defibrillation system
Primary Device ID07613327673357
NIH Device Record Keya5a48797-9eef-468b-b603-1d35e00776f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFEPAK 35 Monitor/Defibrillator
Version Model Number99335
Catalog Number99335-000032U
Company DUNS009251992
Company NamePHYSIO-CONTROL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327673357 [Primary]

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 Date2025-12-26
Device Publish Date2025-12-18

On-Brand Devices [LIFEPAK 35 Monitor/Defibrillator]

00883873766262SP/CO/MET,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN,STD, BT
00883873765609LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
00883873772652LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/C
00883873766255LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/C
00883873765661LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL
00883873765630LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/L
00883873765586LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
00883873765456LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CP
00883873765425LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,WIFI/CELL/LN/CPRIN,STD
00883873761601LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761595LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761588LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761571LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761564LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761557LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761540LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
00883873761533LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
07613327691351CPO,ACLS,LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR,US
07613327691344CPO,ACLS,LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
07613327681864CPO,LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/C
07613327673357CPO,LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
07613327673265CPO,LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
07613327673258CPO,LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,WIFI/CELL/LN/CPRIN,STD
07613327673241CPO,LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CP
07613327673234CPO,LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/L
07613327673227CPO,LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/
07613327673197CPO,LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/C

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.