FDA.reportPublic FDA data

APK

Primary DI
06946725538081
Brand
APK
Company
APK Technology Co.,Ltd.
Model
10050
Device description
Corometrics Compatible MECG Cable, 3 Lead, AHA
Published
2023-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725538081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725538081069467255380816946725538081

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
529691989
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946725554128APKA1414-SR112PU2026-06-26
06946725561157APKA0209-SA082026-06-26
06946725561164APKA0209-SA092026-06-26
06946725561171APKA0209-SP092026-06-26
06946725561188APKA0209-SI092026-06-26
06946725561195APKA0209-SN072026-06-26
06946725561201APKA0209-SN092026-06-26
06946725561218APKA0212-SA01M2026-06-26
06946725561225APKA0212-SA02M2026-06-26
06946725561232APKA0212-SA03M2026-06-26
06946725561249APKA0212-SP01M2026-06-26
06946725561256APKA0212-SP02M2026-06-26
06946725561263APKA0212-SI01M2026-06-26
06946725561270APKA0212-SI02M2026-06-26
06946725561287APKA0212-SI03M2026-06-26
06946725561294APKA0212-SN01M2026-06-26
06946725561300APKA0212-SN02M2026-06-26
06946725561317APKA0212-SN072026-06-26
06946725561324APKA0212-SN07M2026-06-26
06946725561331APKA0212-SA082026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435398CaremedShenzhen 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