APK

Basic Information

• Brand Name: APK
• Primary DI: 06946725540954
• Version / Model: MAS-LNC-10
• Company Name: APK Technology Co.,Ltd.
• Labeler DUNS: 529691989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-20
• Public Version: 1
• Public Version Date: 2023-04-28
• Public Version Status: New
• Public Device Record Key: a16c3437-3db1-47c3-8640-7e6632a2eef4

Device Description

M-tech compatible 14 Pin SpO2 Patient Cable 10 ft

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46617	Tissue saturation oximeter sensor, reprocessed	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06946725540954	GS1