Primary Device ID | 04719878320856 |
NIH Device Record Key | b2ea793c-d48f-4b38-b971-4a182d34d081 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Somnics |
Version Model Number | iBreath |
Company DUNS | 657169335 |
Company Name | SOMNICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Serial Number | false |
Manufacturing Date | true |
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 | true |
Phone | 1-833-766-6427 |
service.us@somnics.com | |
Phone | 1-833-766-6427 |
service.us@somnics.com | |
Phone | 1-833-766-6427 |
service.us@somnics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04719878320856 [Primary] |
IOD | Components, Exercise |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-06 |
Device Publish Date | 2022-11-28 |
04719878320849 | ZeeBud Plus Nasal Dilator (M1) |
04719878320832 | ZeeBud Nasal Dilator |
04719878320856 | iBreath Breathing Training Kit |
04719878321044 | ZEEPAP Nasal Dilator |
04719878321082 | ZeeBud Nasal Dilator (ZD1) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOMNICS 88107678 not registered Live/Pending |
Somnics Inc. 2018-09-06 |
SOMNICS 85646632 4374728 Live/Registered |
SOMNICS, INC. 2012-06-08 |