Embla

GUDID 00382830048484

RemLogic 4.0 Software (English)

Embla Systems Ltd

Sleep disorder interpretive software

• Primary Device ID: 00382830048484
• NIH Device Record Key: 8129e692-91a3-4b21-949a-cf87474ae803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embla
• Version Model Number: 025406
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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	00382830048484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162140

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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: 2019-12-11
• Device Publish Date: 2018-11-20

Devices Manufactured by Embla Systems Ltd

• 00382830025973 - Natus: 2020-02-17 XactTrace Univ Sensor -Thorax
• 00382830027205 - Natus: 2020-02-17 XactTrace Univ Sensor- Abdomen
• 00382830026277 - Xltek: 2020-02-17 XactTrace Snap Sensor Cable - Thorax
• 00382830027076 - Xltek: 2020-02-17 XactTrace Lock - Thorax EBG
• 00382830027083 - Xltek: 2020-02-17 XactTrace Reusable Belt - Small Abdomen
• 00382830027090 - Xltek: 2020-02-17 XactTrace Reusable Belt - Small Thorax
• 00382830027106 - Xltek: 2020-02-17 XactTrace Reusable Belt - Medium Abdomen
• 00382830027113 - Xltek: 2020-02-17 XactTrace Reusable Belt - Medium Thorax