AccuSom
GUDID 00860512000253
Home Sleep Test Device v3
NOVASOM, INC.
Home-use sleep apnoea recording system| Primary Device ID | 00860512000253 |
| NIH Device Record Key | fb98796e-82f3-46f6-b871-7a71a6d2b9fa |
| Commercial Distribution Discontinuation | 2023-04-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AccuSom |
| Version Model Number | 1017-10001-US |
| 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 | 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 |
Customer Support Contacts
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com | |
| Phone | (877) 753-3776 |
| usinfo@bioserenity.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860512000253 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110486
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 | 2 |
| Public Version Date | 2023-04-25 |
| Device Publish Date | 2023-01-13 |
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 |
Trademark Results [AccuSom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUSOM 85118635 4147299 Live/Registered |
NOVASOM, INC. 2010-08-30 |
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