Critikon

GUDID 06946725525760

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 06946725525760
• NIH Device Record Key: dbbfc107-d393-48db-834b-584781897802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Critikon
• Version Model Number: A0314-SW113PU
• 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	06946725525760 [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 [Critikon]

• 06946725525760: A0314-SW113PU
• 06946725525753: A0314-SP113PU
• 06946725525746: A0314-SP113PV
• 06946725525739: A0314-SA113PV
• 06946725525708: A0314-SA113PU