Natus

GUDID 00382830026253

Single Use XactTrace belt - large 20/bx

Embla Systems Ltd

Polysomnograph

• Primary Device ID: 00382830026253
• NIH Device Record Key: cb6f038c-e3d5-4347-8eaa-116ed9338049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 011520
• 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	00382830026253 [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 [Natus]

• 00382830053938: Snap On Cables 60in/150cm Black
• 00382830047708: XactTrace Lock - Ambu - Thorax 80"
• 00382830047463: Single Use Universal RIP Kit - Thorax
• 00382830047456: Single Use Universal RIP Kit - Abdomen
• 00382830027205: XactTrace Univ Sensor- Abdomen
• 00382830026291: XactTrace Snap Sensor Cable, Thorax, 78" cable length
• 00382830026284: XactTrace Snap Sensor Cable - Abdomen, 78" cable length
• 00382830026260: XactTrace Snap Sensor Cable - Abdomen
• 00382830026253: Single Use XactTrace belt - large 20/bx
• 00382830026246: Single Use XactTrace belt - medium 20/bx
• 00382830026239: Single Use XactTrace belt - small 20/bx
• 00382830026222: Single Use XactTrace belt - Pediatric 20/bx
• 00382830025973: XactTrace Univ Sensor -Thorax
• 00382830025942: XactTrace Lock - Thorax
• 00382830025331: Snap On Cable 39in/100cm Green