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
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
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
06946725550748APKDRG-MS165462026-05-22
06946725555316APKPMLQ590DPO2026-05-22
06946725571460APKS410-14302026-05-22
06946725571477APK129332026-05-22
06946725549926APKI-A0212-SY125PUA0212-SY125PU2026-03-19
06946725549933APKI-A0212-SA126PVA0212-SA126PV2026-03-19
06946725549940APKI-A0212-SA126PUA0212-SA126PU2026-03-19
06946725550021APKI-A1424-SA203PUA1424-SA203PU2026-03-19
06946725550038APKI-A1424-SP203PVA1424-SP203PV2026-03-19
06946725550045APKI-A1424-SP203PUA1424-SP203PU2026-03-19
06946725550069APKI-A1501-SR203PUA1501-SR203PU2026-03-19
06946725550076APKI-A0816-SP105PUA0816-SP105PU2026-03-19
06946725550083APKI-A0816-SW105PUA0816-SW105PU2026-03-19
06946725550090APKI-A0816-SR105PUA0816-SR105PU2026-03-19
06946725550106APKI-A0816-SI105PUA0816-SI105PU2026-03-19
06946725550113APKI-A0816-SY105PUA0816-SY105PU2026-03-19
06946725550137APKI-A0816-SP106PVA0816-SP106PV2026-03-19
06946725550144APKI-A0816-SP106PUA0816-SP106PU2026-03-19
06946725550151APKI-A0816-SW106PUA0816-SW106PU2026-03-19
06946725550168APKI-A0816-SR106PUA0816-SR106PU2026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20192253019992KendallCardinal Health 200, LLCIKD2026-05-26
10884521091986NellcorCovidien LPDQA2026-05-25
06946725550748APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725555316APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725571460APKAPK Technology Co.,Ltd.DQA2026-05-22
06946725571477APKAPK Technology Co.,Ltd.IKD2026-05-22
20653405017759CONMEDConmed CorporationIKD2026-03-24
20885380202480KendallCardinal Health 200, LLCIKD2026-03-20
20885380202497KendallCardinal Health 200, LLCIKD2026-03-20
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19