FDA.reportPublic FDA data

Caremed

Primary DI
06970758507615
Brand
Caremed
Company
Shenzhen Caremed Medical Technology Co., Ltd.
Model
AD-BA-10
Catalog number
AD-BA-10
Device description
Caremed ECG lead wire
Published
2019-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06970758507615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970758507615069707585076156970758507615

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544335718
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09
00841034110804ACQUISITION MODULE CABLERPIDSA2016-12-09