Primary Device ID | 00851861007161 |
NIH Device Record Key | f6349593-512a-4e4d-a5cc-682c5c094d71 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Respire Pink Series with DentiTrac - H |
Version Model Number | SPD000US |
Company DUNS | 059636679 |
Company Name | RESPIRE MEDICAL HOLDINGS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | 718-643-7326 |
info@respiremedical.com |
Circumference | 200 Millimeter |
Special Storage Condition, Specify | Between 0 and 0 *Store in water when not in use |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851861007161 [Primary] |
PLC | Sleep Appliances With Patient Monitoring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-02-17 |
Device Publish Date | 2017-07-14 |
00851861007253 - Respire Pink AT EF | 2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older. |
00851861007260 - Respire Pink AT Hard | 2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older. |
00851861007277 - Respire Pink AT Hard/Soft | 2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older. |
00851861007000 - Blue Series - H/S | 2020-02-17 Respire Blue Series (Hard/Soft) |
00851861007017 - Blue Series - Hard | 2020-02-17 Respire Blue Series - Hard |
00851861007024 - Blue Series - EF | 2020-02-17 Respire Blue Series EF |
00851861007031 - Pink Micro - Hard | 2020-02-17 Respire Pink (Herbst) Micro - Hard |
00851861007048 - Pink Micro - H/S | 2020-02-17 Respire Pink Micro (Herbst) Hard/Soft |