FDA.reportPublic FDA data

Caremed

Primary DI
06931973435398
Brand
Caremed
Company
Shenzhen Caremed Medical Technology Co., Ltd.
Model
LSI-ECGL40
Device description
Caremed Patient Cable and Leadwires
Published
2026-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153188000Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.2016-10-24DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06931973435398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931973435398069319734353986931973435398

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Regulatory Flags#

DUNS number
544335718
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931973400563CaremedC503-012026-07-09
06931973400730CaremedC533-162026-07-09
06931973400785CaremedC503-492026-07-09
06931973403939CaremedED5R-90S-A2026-07-09
06931973410326CaremedC503-162026-07-09
06931973410333CaremedC523-162026-07-09
06931973410340CaremedC543-162026-07-09
06931973410364CaremedC403B-49R2026-07-09
06931973410371CaremedC903-912026-07-09
06931973410388CaremedC410B-15R2026-07-09
06931973410395CaremedC403B-1172026-07-09
06931973410401CaremedC410-21X2026-07-09
06931973410418CaremedC410B-153R2026-07-09
06931973410425CaremedC103F-49R2026-07-09
06931973410432CaremedC803-49R2026-07-09
06931973410449CaremedC803-01X2026-07-09
06931973410456CaremedC403B-01X2026-07-09
06931973410647CaremedC403S-49R2026-07-09
06931973410678CaremedSA30B-482026-07-09
06931973410685CaremedSA30B-752026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435404CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435411CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973439082CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457116CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457123CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457130CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457147CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457154CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457161CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457185CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457192CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457208CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457215CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457246CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
08720938410284QMAPPFysicon B.V.DSA2026-06-26
G662ME590030M31MaguireMaguire Enterprises, Inc.DSA2026-06-24
G662ME5921011MaguireMaguire Enterprises, Inc.DSA2026-06-10
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19