Datex

GUDID 06946725520079

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 06946725520079
• NIH Device Record Key: 9bbce829-2816-4924-99eb-95fa0f20d361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Datex
• Version Model Number: A0424-SA203PU
• Company DUNS: 529691989
• Company Name: APK Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946725520079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082846

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-06

On-Brand Devices [Datex]

• 06946725520109: A0424-SW203PW
• 06946725520093: A0424-SP203PU
• 06946725520086: A0424-SP203PV
• 06946725520079: A0424-SA203PU
• 06946725520062: A0424-SA203PV
• 06946725520048: A0424-SW101PU
• 06946725520031: A0424-SP101PU
• 06946725520024: A0424-SP101PV
• 06946725520017: A0424-SA101PU
• 06946725520000: A0424-SA101PV