Tempus LS-MANUAL

FDA UDI

Class II (US FDA UDI)

by Schiller Corp.

Identity

Trade Name: Tempus LS-MANUAL FDA UDI
Generic Name: Physiologic-monitoring defibrillation system FDA UDI
Device Name: The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings. FDA UDI
Model / Reference: 3.940589 FDA UDI
Description: The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings. FDA UDI

Identifiers

Catalog Number: 00-3020 FDA UDI
Primary DI / UDI-DI: 07613365002737 FDA UDI
510(k) Number: K200849 FDA UDI
FDA Product Code: DRO FDA UDI
DPS FDA UDI
LIX FDA UDI
LDD FDA UDI
GMDN Term: Physiologic-monitoring defibrillation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5550 FDA UDI
870.2340 FDA UDI
870.5210 FDA UDI
870.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Physiologic-monitoring defibrillation system

Tempus LS-MANUAL by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physiologic-monitoring defibrillation system.

LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
R SERIES — Zoll Medical Corporation · Class II
LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
X SERIES — Zoll Medical Corporation · Class II
LIFEPAK 35 Monitor/Defibrillator — PHYSIO-CONTROL, Inc. · Class III
LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
X SERIES — Zoll Medical Corporation · Class II

Cleared under the same submission

K200849 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Schiller Corp.

Sources (1)

FDA UDI 4e340db2-db5a-4a47-ba9d-36ce8f291242 36 fields · synced May 30, 2026