Embla

GUDID 00382830048484

RemLogic 4.0 Software (English)

Embla Systems Ltd

Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software Sleep disorder interpretive software 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