Invivo

GUDID 06946725526118

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 06946725526118
• NIH Device Record Key: e471325a-eb1b-4429-bd77-5bf2d8cb74d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invivo
• Version Model Number: A0915-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	06946725526118 [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 [Invivo]

• 06946725526118: A0915-SW113PU
• 06946725526101: A0915-SP113PU
• 06946725526095: A0915-SP113PV
• 06946725526088: A0915-SA113PU
• 06946725526071: A0915-SA113PV