Respire Pink Series with DentiTrac - H

GUDID 00851861007161

Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.

RESPIRE MEDICAL HOLDINGS LLC

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00851861007161
NIH Device Record Keyf6349593-512a-4e4d-a5cc-682c5c094d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespire Pink Series with DentiTrac - H
Version Model NumberSPD000US
Company DUNS059636679
Company NameRESPIRE MEDICAL HOLDINGS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone718-643-7326
Emailinfo@respiremedical.com

Device Dimensions

Circumference200 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in water when not in use

Device Identifiers

Device Issuing AgencyDevice ID
GS100851861007161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLCSleep Appliances With Patient Monitoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-17
Device Publish Date2017-07-14

Devices Manufactured by RESPIRE MEDICAL HOLDINGS LLC

00851861007253 - Respire Pink AT EF2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
00851861007260 - Respire Pink AT Hard2020-02-21 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/Soft2020-02-21 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
00851861007000 - Blue Series - H/S2020-02-17 Respire Blue Series (Hard/Soft)
00851861007017 - Blue Series - Hard2020-02-17 Respire Blue Series - Hard
00851861007024 - Blue Series - EF2020-02-17 Respire Blue Series EF
00851861007031 - Pink Micro - Hard2020-02-17 Respire Pink (Herbst) Micro - Hard
00851861007048 - Pink Micro - H/S2020-02-17 Respire Pink Micro (Herbst) Hard/Soft

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