Philips

GUDID 06946725527146

APK Technology Co.,Ltd.

Electrocardiographic lead set, reusable

• Primary Device ID: 06946725527146
• NIH Device Record Key: 948a8330-be65-4be2-a8fe-332e0255086f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips
• Version Model Number: A0003D06-001
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946725527146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170536

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-06
• Device Publish Date: 2018-07-06

On-Brand Devices [ Philips]

• 06946725527207: A0004D06-001
• 06946725527191: A0004D06
• 06946725527184: A0004D05-001
• 06946725527177: A0004D05
• 06946725527160: A0004D03-001
• 06946725527153: A0004D03
• 06946725527146: A0003D06-001
• 06946725527139: A0003D06
• 06946725527122: A0003D05-001
• 06946725527108: A0003D03-001
• 06946725527092: A0003D03