FDA.reportPublic FDA data

APK

Primary DI
06946725540954
Brand
APK
Company
APK Technology Co.,Ltd.
Model
MAS-LNC-10
Device description
M-tech compatible 14 Pin SpO2 Patient Cable 10 ft
Published
2023-04-20
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
DQAOximeter
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725540954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725540954069467255409546946725540954

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, reprocessedA photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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
06946725550748APKDRG-MS165462026-05-22
06946725555316APKPMLQ590DPO2026-05-22
06946725571460APKS410-14302026-05-22
06946725571477APK129332026-05-22
06946725550731APKMAS-18952026-05-21
06946725558331APKS110S-68D02026-05-21
06946725571453APKMDR-0012-00-0516-022026-05-21
06946725527948APKA1418-SN072025-09-23
06946725527610APKA1418-SP032025-09-22
06946725504017APKA-DE-142026-04-14
06946725550649APKS210S-12502026-04-14
06946725550656APKS110S-12502026-04-14
06946725550663APKS410S-137D02026-04-14
06946725555323APKA-DE-122026-04-14
06946725555330APKA-DE-A2222Z-52026-04-14
06946725555347APKA-DE-A2222Z-X2026-04-14
06946725555354APKA-DE-A2525Y2026-04-14
06946725555361APKA-DE-A2525Y-X2026-04-14
06946725555378APKA-DE-A3030Y2026-04-14
06946725555385APKA-DE-A3030Y-X2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-06-04
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27