FDA.reportPublic FDA data

Respire Pink AT Hard

Primary DI
00851861007260
Brand
Respire Pink AT Hard
Company
RESPIRE MEDICAL HOLDINGS LLC
Model
SPAT000US
Device description
Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
Published
2020-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192127000Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings2020-02-05LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851861007260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851861007260008518610072608518610072600851861007260

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.

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
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
00851861007161Respire Pink Series with DentiTrac - HSPD000US2017-07-14
00851861007178Respire Pink Series H/S with DentiTracSPD020US2017-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850077473067Individual EMA Straps(EMAST15W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473074Individual EMA Straps(EMAST16W)EMA SLEEP INCORPORATEDLRK2026-08-14
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00850077473098Individual EMA Straps(EMAST18W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473104Individual EMA Straps(EMAST19W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473111Individual EMA Straps(EMAST20W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473128Individual EMA Straps(EMAST21W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473135Individual EMA Straps(EMAST13Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473142Individual EMA Straps(EMAST14Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473159Individual EMA Straps(EMAST15Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473166Individual EMA Straps(EMAST16Y)EMA SLEEP INCORPORATEDLRK2026-08-14
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00850077473180Individual EMA Straps(EMAST18Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473197Individual EMA Straps(EMAST19Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473203Individual EMA Straps(EMAST20Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473210Individual EMA Straps(EMAST21Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473227Individual EMA Straps(EMAST13B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473234Individual EMA Straps(EMAST14B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473241Individual EMA Straps(EMAST15B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473258Individual EMA Straps(EMAST16B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473265Individual EMA Straps(EMAST17B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473272Individual EMA Straps(EMAST18B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473289Individual EMA Straps(EMAST19B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473296Individual EMA Straps(EMAST20B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473302Individual EMA Straps(EMAST21B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473319Individual EMA Straps(EMAST13C)EMA SLEEP INCORPORATEDLRK2026-08-14