FDA.reportPublic FDA data

LIFEE

Primary DI
00850067829034
Brand
LIFEE
Company
Caf Medical Solutions, Inc
Model
LE-12CH
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
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220362000LE-12CHCaf Medical Solutions, Inc.2022-03-25DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850067829034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850067829034008500678290348500678290340850067829034

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

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
00850067829041LIFEELM-82025-02-12
00850067829058LIFEELM-102025-02-12
00850067829065LIFEELM-122025-02-12
00850067829072LIFEELM-152025-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DPS2026-01-29
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