BIOSYS

GUDID 06946725525661

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 06946725525661
• NIH Device Record Key: 10f350b7-a91d-40e6-a50f-e4220ae45169
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOSYS
• Version Model Number: A0219-SA123PU
• 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	06946725525661 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-10

On-Brand Devices [BIOSYS]

• 06946725525722: A0219-SW123PU
• 06946725525685: A0219-SP123PU
• 06946725525678: A0219-SP123PV
• 06946725525661: A0219-SA123PU
• 06946725525654: A0219-SA123PV