Xltek

GUDID 00382830027076

XactTrace Lock - Thorax EBG

Embla Systems Ltd

Polysomnograph

• Primary Device ID: 00382830027076
• NIH Device Record Key: a646ef28-ea8a-4ee8-8339-7b7675270fdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xltek
• Version Model Number: 1421023
• 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: 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	00382830027076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043132

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-17
• Device Publish Date: 2016-10-25

On-Brand Devices [Xltek]

• 00382830043533: Sandman Elite 9.3 Install CD ENU
• 00382830043489: Enterprise 5.2 Installation CD
• 00382830043458: RemLogic 3.4.1 (ENU) Software
• 00382830043441: RemLogic 3.3.2 Installation CD ENU
• 00382830027434: Snap On Cable 30in/75cm Black
• 00382830027229: XactTrace Universal Belt
• 00382830027199: XactTrace Reusable Belt - Large Abdomen 78" cable length
• 00382830027182: XactTrace Reusable Belt - Large Thorax 78 cable length "
• 00382830027175: XactTrace Reusable Belt - Small Abdomen 78" cable length
• 00382830027168: XactTrace Reusable Belt - Small Thorax 78 cable Length "
• 00382830027151: XactTrace Reusable Belt - Medium Abdomen 78" cable length
• 00382830027144: XactTrace Reusable Belt-Med Thorax 78 cable length "
• 00382830027137: XactTrace Reusable Belt - Large Thorax
• 00382830027120: XactTrace Reusable Belt - Large Abdomen
• 00382830027113: XactTrace Reusable Belt - Medium Thorax
• 00382830027106: XactTrace Reusable Belt - Medium Abdomen
• 00382830027090: XactTrace Reusable Belt - Small Thorax
• 00382830027083: XactTrace Reusable Belt - Small Abdomen
• 00382830027076: XactTrace Lock - Thorax EBG
• 00382830026789: Snap on Cable 24"/61cm Red
• 00382830026772: Snap on Cable 24"/60cm Green
• 00382830026277: XactTrace Snap Sensor Cable - Thorax
• 00382830025393: Snap Electrode Breakout Cable 40"
• 00382830025386: Snap On Cables120in/300cm Black
• 00382830025379: Snap On Cables 120in/300cm White
• 00382830025362: EKG Snap On Cables 78in/200cm
• 00382830025348: Snap On Cables 39in/100cm Orange
• 00382830024662: P32 Pulse Oxi LP Cable
• 00382830024655: Oximeter Embletta/Embla7000 XPOD
• 00382830023924: Sandman Codec Software V.2.0 CD-Elite
• 00382830023849: Embletta MPR TX Proxy
• 00382830023788: Embletta MPR ST+ Proxy
• 00382830023771: Embletta MPR ST Proxy
• 00382830023764: Embletta MPR PG
• 00382830023757: Embletta MPR Base