FDA.reportPublic FDA data

Nasal PCA

Primary DI
09350902001423
Brand
Nasal PCA
Company
GO MEDICAL INDUSTRIES PTY. LTD.
Model
Nasal Inhaler - 3 Minute Lockout (10mL) Screw Top
Catalog number
AAM3003
Published
2017-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KCOInhaler, Nasal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350902001430PackageGS120In Commercial Distribution
09350902001423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350902001430093509020014309350902001430
09350902001423093509020014239350902001423

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
757634266
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350902000396Flow Control TubingFCT 10mL/5minFCT10-5m2016-09-24
09350902000426Flow Control TubingFCT 10mL/15minFCT10-15m2016-09-24
09350902000457Flow Control TubingFCT 10mL/30minFCT10-30m2016-09-24
09350902000488Flow Control TubingFCT 10mL/60minFCT10-60m2016-09-24
09350902000518Flow Control TubingFCT 10mL/2hFCT10-2h2016-09-24
09350902000549Flow Control TubingFCT 10mL/4hFCT10-4h2016-09-24
09350902000570Flow Control TubingFCT 10mL/6hFCT10-6h2016-09-24
09350902000600Flow Control TubingFCT 10mL/8hFCT10-8h2016-09-24
09350902000631Flow Control TubingFCT 10mL/12hFCT10-12h2016-09-24
09350902000662Flow Control TubingFCT 10mL/24hFCT10-24h2016-09-24
09350902000693Flow Control TubingFCT 10mL/48hFCT10-48h2016-09-24
09350902000723Flow Control TubingFCT 10mL/72hFCT10-72h2016-09-24
09350902000754Flow Control TubingFCT 30mL/5minFCT30-5m2017-05-16
09350902000785Flow Control TubingFCT 30mL/15minFCT30-15m2017-05-16
09350902000815Flow Control TubingFCT 30mL/30minFCT30-30m2017-05-16
09350902000846Flow Control TubingFCT 30mL/60minFCT30-60m2017-05-16
09350902000877Flow Control TubingFCT 30mL/2hFCT30-2h2017-05-16
09350902000907Flow Control TubingFCT 30mL/4hFCT30-4h2017-05-16
09350902000938Flow Control TubingFCT 30mL/6hFCT30-6h2017-05-16
09350902000969Flow Control TubingFCT 30mL/8hFCT30-8h2017-05-16

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
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
09350902001447Nasal PCAGO MEDICAL INDUSTRIES PTY. LTD.KCO2017-05-17