Drager

GUDID 06946725527238

APK Technology Co.,Ltd.

Electrocardiographic lead set, reusable

• Primary Device ID: 06946725527238
• NIH Device Record Key: a88f7e80-9b54-4748-aea5-cda2627ebab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drager
• Version Model Number: A0005D05
• 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	06946725527238 [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 [ Drager ]

• 06946725527269: A0005D06-001
• 06946725527252: A0005D06
• 06946725527245: A0005D05-001
• 06946725527238: A0005D05
• 06946725527221: A0005D03-001
• 06946725527214: A0005D03