Mindray

GUDID 06946725520680

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 06946725520680
• NIH Device Record Key: 589c6d7c-3d30-49b7-bb67-de7a9df2bfd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mindray
• Version Model Number: A1318-SP111PV
• 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	06946725520680 [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 [Mindray]

• 06946725520703: A1318-SW111PU
• 06946725520697: A1318-SP111PU
• 06946725520680: A1318-SP111PV
• 06946725520673: A1318-SA111PU
• 06946725520666: A1318-SA111PV
• 06946725520642: A0509-SW111PU
• 06946725520635: A0509-SP111PU
• 06946725520628: A0509-SP111PV
• 06946725520611: A0509-SA111PU
• 06946725520604: A0509-SA111PV
• 06946725520581: A1318-SW129PU
• 06946725520574: A1318-SP129PU
• 06946725520567: A1318-SP129PV
• 06946725520550: A1318-SA129PU
• 06946725520543: A1318-SA129PV
• 06946725528631: MDR-009-004782-00-DP
• 06946725528624: MDR-009-004786-00-DP
• 06946725528617: MDR-009-004782-00
• 06946725528600: MDR-009-004786-00
• 06946725529041: Mindray Bene/Pass-Philips 5L ECG Adapter
• 06946725529034: Mindray Pano-Philips 3L ECG Adapter
• 06946725528686: MDR-009-004782-00
• 06946725528679: MDR-009-004786-00