Sierra Summit/Ascent

GUDID 00840067100332

Sierra Summit VEP LED Goggles

CADWELL INDUSTRIES, INC.

Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph

• Primary Device ID: 00840067100332
• NIH Device Record Key: c7d02e70-53bb-4f90-856c-8fe61233de39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sierra Summit/Ascent
• Version Model Number: 199277-200
• Company DUNS: 098554157
• Company Name: CADWELL INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067100332 [Primary]

FDA Product Code

• OLV: Standard 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-05

On-Brand Devices [Sierra Summit/Ascent]

• 00840067102800: Summit 10 Ohn Shielded Headphones
• 00840067100356: Sierra Summit Footswitch
• 00840067100332: Sierra Summit VEP LED Goggles
• 00840067100127: HDA280 Sennheiser Headphone
• 00840067100110: Summit Tendon Hammer