FDA.reportPublic FDA data

APK

Primary DI
06946725579435
Brand
APK
Company
APK Technology Co.,Ltd.
Model
PH-989803173131-S
Device description
Disposable ECG Lead Wire
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170536000ECG Disposable Lead WireAPK Technology Co., Ltd.2017-04-24DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725579435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725579435069467255794356946725579435

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA 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 to assist electrode placement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529691989
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946725502341APKI-MCB-03VA-10AS-01002026-10-22
06946725513606APKI-A0209-SA203PUA0209-SA203PU2026-03-10
06946725513613APKI-A0209-SP203PVA0209-SP203PV2026-03-10
06946725513620APKI-A0209-SP203PUA0209-SP203PU2026-03-10
06946725513637APKI-A0209-SW203PUA0209-SW203PU2026-03-10
06946725513644APKI-A0209-SR203PUA0209-SR203PU2026-03-10
06946725513651APKI-A0209-SI203PUA0209-SI203PU2026-03-10
06946725513668APKI-A0209-SY203PUA0209-SY203PU2026-03-10
06946725513675APKI-A0210-SA195PVA0210-SA195PV2026-03-10
06946725513682APKI-A0210-SA195PUA0210-SA195PU2026-03-10
06946725513699APKI-A0210-SP195PVA0210-SP195PV2026-03-10
06946725513705APKI-A0210-SP195PUA0210-SP195PU2026-03-10
06946725513712APKI-A0210-SW195PUA0210-SW195PU2026-03-10
06946725513729APKI-A0210-SR195PUA0210-SR195PU2026-03-10
06946725513736APKI-A0210-SI195PUA0210-SI195PU2026-03-10
06946725513743APKI-A0210-SY195PUA0210-SY195PU2026-03-10
06946725513750APKI-A0220-SA203PVA0220-SA203PV2026-03-10
06946725513767APKI-A0220-SA203PUA0220-SA203PU2026-03-10
06946725513774APKI-A0220-SP203PVA0220-SP203PV2026-03-10
06946725513781APKI-A0220-SP203PUA0220-SP203PU2026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17