FDA.reportPublic FDA data

Respire Pink Series with DentiTrac - H

Primary DI
00851861007161
Brand
Respire Pink Series with DentiTrac - H
Company
RESPIRE MEDICAL HOLDINGS LLC
Model
SPD000US
Device description
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
Published
2017-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLCSleep Appliances With Patient Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLCSleep Appliances With Patient MonitoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170692000Respire Pink Series with DentiTracRespire Medical Holding2017-05-26LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851861007161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851861007161008518610071618518610071610851861007161

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference200Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in water when not in use

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
718-643-7326info@respiremedical.com

Regulatory Flags#

DUNS number
059636679
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851861007253Respire Pink AT EFSPAT030US2020-02-13
00851861007260Respire Pink AT HardSPAT000US2020-02-13
00851861007277Respire Pink AT Hard/SoftSPAT020US2020-02-13
00851861007000Blue Series - H/SSB020US2016-09-20
00851861007017Blue Series - HardSB000US2016-09-20
00851861007024Blue Series - EFSB030US2016-09-20
00851861007031Pink Micro - HardSPM001US2016-09-20
00851861007048Pink Micro - H/SSPM020US2016-09-20
00851861007055Pink Micro - EFSPM030US2016-09-20
00851861007062Pink Series - EFSP030US2016-09-20
00851861007079Pink Series - H/SSP020US2016-09-20
00851861007086Pink Series - HardSP000US2016-09-20
00851861007093Blue + HardSBP000US2017-06-15
00851861007109Blue + Hard/SoftSBP020US2017-06-15
00851861007116Blue EF + HardSBP030US2017-06-15
00851861007123Blue EF + Hard/SoftSBP040US2017-06-15
00851861007130Respire Pink+ HardSPP000US2017-09-15
00851861007147Respire Pink+ H/SSPP020US2017-09-15
00851861007154Respire Pink EF+SPP030US2017-09-15
00851861007178Respire Pink Series H/S with DentiTracSPD020US2017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESPLC2026-04-24
00863039000454Prosomnus CA Sleep and Snore Device with Patient MonitoringPROSOMNUS SLEEP TECHNOLOGIESPLC2017-12-06
00851861007222Respire Pink+ Hard with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-09-15
00851861007246Respire Pink EF+ with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-09-15
00851861007178Respire Pink Series H/S with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007185Respire Pink Series EF with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007192Respire Pink Series Micro with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007208Respire Pink Series Micro H/S with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007215Respire Pink Series EF Micro with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00863039000430Prosomnus IA with Patient MonitoringPROSOMNUS SLEEP TECHNOLOGIESPLC2017-06-21
00863039000447Prosomnus IA MicrO2 with Patient MonitoringPROSOMNUS SLEEP TECHNOLOGIESPLC2017-06-21
00851861007239Respire Pink+ H/S with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-06-19