FDA.reportPublic FDA data

INBRIJA®

Primary DI
00310144300011
Brand
INBRIJA®
Company
Merz Pharmaceuticals, LLC
Model
Inbrija Device
Published
2022-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00310144300011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310144300011003101443000113101443000110310144300011

GMDN Terms#

Term, Definition table
TermDefinition
Dry powder inhalerA hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways. Commonly known as a dry powder inhaler (DPI), it is a portable device typically carried in the pocket or a handbag (purse) of a patient for convenient access. This form of medicine administration is an alternative to aerosol inhalation and may induce the patient to greater inhalational effort. This is a reusable device intended for single-patient use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)367-5109acordamc@eversana.com

Regulatory Flags#

DUNS number
126209282
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

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
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