FDA.reportPublic FDA data

LIFEE

Primary DI
00850067829065
Brand
LIFEE
Company
Caf Medical Solutions, Inc
Model
LM-12
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MLDMonitor, St Segment With Alarm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLDMonitor, St Segment With AlarmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221879000Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.2022-08-10MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850067829065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850067829065008500678290658500678290650850067829065

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043862669
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850067829003LIFEELMPLUS-122025-02-12
00850067829010LIFEELMPLUS-152025-02-12
00850067829027LIFEELMPLUS-172025-02-12
00850067829034LIFEELE-12CH2025-02-12
00850067829041LIFEELM-82025-02-12
00850067829058LIFEELM-102025-02-12
00850067829072LIFEELM-152025-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMLD2026-04-15
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-03-09
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-11-17
06944413838406Patient Monitor Edan Instruments, Inc.MLD2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.MLD2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-05-06
00850067829003LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829010LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829027LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829041LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829058LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829072LIFEECaf Medical Solutions, IncMLD2025-02-12
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgMLD2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgMLD2024-11-27
06944413815889Patient MonitorEdan Instruments, Inc.MLD2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.MLD2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.MLD2024-06-17
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMLD2024-06-07
00732094237221Welch Allyn, Inc.WELCH ALLYN, INC.MLD2023-09-18