Spacelabs

GUDID 06946725527283

APK Technology Co.,Ltd.

Electrocardiographic lead set, reusable

• Primary Device ID: 06946725527283
• NIH Device Record Key: 62108f3b-bef8-47d3-9c2c-a0fdc90e6d28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spacelabs
• Version Model Number: A0006D03-001
• 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	06946725527283 [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 [Spacelabs]

• 06946725527306: A0006D05-001
• 06946725527290: A0006D05
• 06946725527283: A0006D03-001
• 06946725527276: A0006D03
• 06946725527993: 6946725527993
• 06946725529027: Spacelabs Ultra-Philips 5L ECG Adapter
• 06946725529010: Spacelabs Ultra-Philips 3L ECG Adapter