Embla Systems

GUDID 00382830025935

XactTrace Lock - Abdomen EBG

Embla Systems Ltd

Polysomnograph

• Primary Device ID: 00382830025935
• NIH Device Record Key: 3bac3050-fb94-47d3-a7f0-3972d18df8a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embla Systems
• Version Model Number: 1421021
• Company DUNS: 203408612
• Company Name: Embla Systems 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00382830025935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173793

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [Embla Systems]

• 00382830025935: XactTrace Lock - Abdomen EBG
• 00382830025928: XactTrace Lock - Abdomen