Primary Device ID | 00851826007045 |
NIH Device Record Key | f56d37ff-ab4a-4cc4-8d20-e05585064a9b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fusion Flex |
Version Model Number | L7001 |
Company DUNS | 623527962 |
Company Name | SOMNOMED, 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 | false |
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 |
Phone | 888-447-6673 |
customerservice@somnomed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851826007045 [Primary] |
LRK | Device, Anti-Snoring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-14 |
00851826007199 - SomnoDent AVANT | 2019-09-06 SomnoDent Avant kit with Large Strap Set |
00851826007205 - SomnoDent AVANT | 2019-09-06 SomnoDent Avant kit with Medium Strap Set |
00851826007212 - SomnoDent AVANT | 2019-09-06 SomnoDent Avant kit with Small Strap Set |
00851826007229 - SomnoDent AVANT | 2019-09-06 SomnoDent AVANT Strap Set Small |
00851826007236 - SomnoDent AVANT | 2019-09-06 SomnoDent AVANT Strap Set Medium |
00851826007243 - SomnoDent AVANT | 2019-09-06 SomnoDent Avant Strap Set L |
00851826007007 - SomnoDent Air | 2018-07-06 Oral Device For The Treatment Of Obstructive Sleep Apnea. |
00851826007014 - SomnoDent Air+ | 2018-07-06 Oral Device For The Treatment Of Obstructive Sleep Apnea. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FUSION FLEX 97531630 not registered Live/Pending |
Stephen Gould Corporation 2022-08-02 |
FUSION FLEX 86545271 not registered Dead/Abandoned |
HBI Branded Apparel Enterprises, LLC 2015-02-25 |