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LIFEPAK 35 Monitor/Defibrillator

FDA UDI

Class III (US FDA UDI)

by PHYSIO-CONTROL, Inc.

Identity

Trade Name
LIFEPAK 35 Monitor/Defibrillator FDA UDI
Generic Name
Physiologic-monitoring defibrillation system FDA UDI
Device Name
LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR FDA UDI
Model / Reference
70335 FDA UDI
Description
LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR FDA UDI

Identifiers

Catalog Number
70335-000214 FDA UDI
Primary DI / UDI-DI
00883873761540 FDA UDI
PMA Number
P160026 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Physiologic-monitoring defibrillation system FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Physiologic-monitoring defibrillation system

A comprehensive monitor defibrillator designed to provide timely and effective cardiac resuscitation in emergency situations.

Similar devices

Also classified as Physiologic-monitoring defibrillation system.

Cleared under the same submission

P160026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PHYSIO-CONTROL, Inc.

Sources (1)

  • FDA UDI 1c2d48e5-00cf-4711-94c7-ec69f8ce331c 36 fields · synced Jul 8, 2026