FDA.reportPublic FDA data

SINUCLEANSE NASAL DRY SALT INHALER

Primary DI
00646011701002
Brand
SINUCLEANSE NASAL DRY SALT INHALER
Company
Ascent Consumer Products Inc
Model
00-70100
Device description
DRY SALT INHALER
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCONasal Spray, Ent Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCONasal Spray, Ent DeliveryEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646011701002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646011701002006460117010026460117010020646011701002

GMDN Terms#

Term, Definition table
TermDefinition
Dry salt inhalation therapy deviceA hand-held inhaler prefilled with salt crystals (e.g., natural Miocene halit) and used to provide an inhalation of salt particles through the mouth and into the bronchial airways. Commonly known as a saltpipe, it is a plastic container, containing the salt crystals, with a mouthpiece to enable inhalation. The inhaled sodium (Na) content and salt particles are believed to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways. This is a reusable device intended for single-patient use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1888-547-5492cs@ascentconsumerproducts.com

Regulatory Flags#

DUNS number
078396381
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00646011702009SINUCLEANSE BRONCHIAL DRY SALT INHALER00-702002023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850040983050WoodyKnowsM&M Pure Air Systems LLCKCO2026-05-19
00850040983067WoodyKnowsM&M Pure Air Systems LLCKCO2026-05-19
00850040983074WoodyKnowsM&M Pure Air Systems LLCKCO2026-05-19
00850040983081WoodyKnowsM&M Pure Air Systems LLCKCO2026-05-19
00850040983098WoodyKnowsM&M Pure Air Systems LLCKCO2026-05-19
00850040983104WoodyKnowsM&M Pure Air Systems LLCKCO2026-05-19
00850027492889Naväge BabyRhinosystems, Inc.KCO2025-10-29
00850027492735Naväge BabyRhinosystems, Inc.KCO2024-11-15
10827989004105Health Care Logistics, Inc®Health Care Logistics, Inc.KCO2024-05-03
10827989004112Health Care Logistics, Inc®Health Care Logistics, Inc.KCO2024-05-03
00827989004108Health Care Logistics, Inc®Health Care Logistics, Inc.KCO2024-05-03
00827989004115Health Care Logistics, Inc®Health Care Logistics, Inc.KCO2024-05-03
00646011702009SINUCLEANSE BRONCHIAL DRY SALT INHALERAscent Consumer Products IncKCO2023-12-20
08437023259016Eau de Quinton Pediatric Nasal Hygiene 100 mlLABORATOIRES QUINTON INTERNATIONAL SLKCO2023-01-24
08437023259023Eau de Quinton Daily Nasal Hygiene 100 mlLABORATOIRES QUINTON INTERNATIONAL SLKCO2023-01-24
08437023259030Eau de Quinton Action Plus Nasal Hygiene 100 mlLABORATOIRES QUINTON INTERNATIONAL SLKCO2023-01-24
00310144300011INBRIJA®Merz Pharmaceuticals, LLCKCO2022-11-28
00310742015904Mentholatum(R) VaporDuo(TM)MENTHOLATUM COMPANY, THEKCO2020-02-07
00310742915907Mentholatum(R) VaporDuo(TM)MENTHOLATUM COMPANY, THEKCO2020-02-07
09350902001362Nasal PCAGO MEDICAL INDUSTRIES PTY. LTD.KCO2017-05-17
09350902001386Nasal PCAGO MEDICAL INDUSTRIES PTY. LTD.KCO2017-05-17
09350902001409Nasal PCAGO MEDICAL INDUSTRIES PTY. LTD.KCO2017-05-17
09350902001423Nasal PCAGO MEDICAL INDUSTRIES PTY. LTD.KCO2017-05-17
09350902001447Nasal PCAGO MEDICAL INDUSTRIES PTY. LTD.KCO2017-05-17