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LIFEPAK® 15 monitor/defibrillator

FDA UDI

Class III (US FDA UDI)

by PHYSIO-CONTROL, Inc.

Identity

Trade Name
LIFEPAK® 15 monitor/defibrillator FDA UDI
Generic Name
Physiologic-monitoring defibrillation system FDA UDI
Device Name
15AACBABBABABAAAAAAAAAAALP15 MONITOR/DEFIB FDA UDI
Model / Reference
99577 FDA UDI
Description
15AACBABBABABAAAAAAAAAAALP15 MONITOR/DEFIB FDA UDI

Identifiers

Catalog Number
99577-000046 FDA UDI
Primary DI / UDI-DI
00883873988022 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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Physiologic-monitoring defibrillation system

The LIFEPAK 15 monitor/defibrillator is a comprehensive medical device designed to provide life-saving treatment in emergency situations. This device enables users to manually or automatically deliver electrical shocks to the heart, and also provides monitoring and tracking features to help manage patients' cardiac conditions.

Similar devices

Also classified as Physiologic-monitoring defibrillation system.

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 f01178b9-e550-43c5-ba2f-eb2061c2ca13 35 fields · synced Oct 6, 2026