AccuSom

GUDID 00860512000208

Sleep apnea diagnosic device

NOVASOM, INC.

Home-use sleep apnoea recording system

• Primary Device ID: 00860512000208
• NIH Device Record Key: e2a38528-97bf-4034-8722-d8d448289e99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuSom
• Version Model Number: NS2010
• Company DUNS: 808379150
• Company Name: NOVASOM, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com
• Phone: 4156138421
• Email: lyates@novasom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860512000208 [Primary]

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: 3
• Public Version Date: 2018-06-08
• Device Publish Date: 2016-11-30

On-Brand Devices [AccuSom]

• 00860512000208: Sleep apnea diagnosic device
• 00860512000246: Chain of Custody Disposable Sensors
• 00860512000239: Device box
• 00860512000222: Breath Sensor
• 00860512000215: Chain of Custody Patient Interface Dongle
• 00860512000253: Home Sleep Test Device v3
• 00860512000291: Home Sleep Test Kit v3
• 00860512000277: Breath Sensor v3
• 00860512000260: Chest Sensor v3