FDA.reportPublic FDA data

WoodyKnows

Primary DI
00850040983081
Brand
WoodyKnows
Company
M&M Pure Air Systems LLC
Model
UB1
Published
2026-05-19
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850040983081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040983081008500409830818500409830810850040983081

GMDN Terms#

Term, Definition table
TermDefinition
Nasal inhalerA hand-held device designed to administer medication directly into the nares of a patient, typically for the purpose of alleviating symptoms of the common cold and/or sinus ailments. It is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. This is a reusable device that must be filled prior to use and is intended for single-patient use.

Regulatory Flags#

DUNS number
080704335
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040983036WoodyKnowsMT12026-05-20
00850040983043WoodyKnowsMT22026-05-20
00850040983005WoodyKnowsBP12026-05-19
00850040983012WoodyKnowsBP22026-05-19
00850040983029WoodyKnowsBP32026-05-19
00850040983050WoodyKnowsSD12026-05-19
00850040983067WoodyKnowsSD22026-05-19
00850040983074WoodyKnowsSD32026-05-19
00850040983098WoodyKnowsUB22026-05-19
00850040983104WoodyKnowsUB32026-05-19
00850040983111WoodyKnowsND12026-05-19
00850040983128WoodyKnowsND22026-05-19
00850040983135WoodyKnowsND32026-05-19
00850040983142WoodyKnowsND42026-05-19

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
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
00646011701002SINUCLEANSE NASAL DRY SALT INHALERAscent Consumer Products IncKCO2023-12-20
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