Nasal PCA

Basic Information

• Brand Name: Nasal PCA
• Primary DI: 09350902001362
• Version / Model: Nasal Inhaler - No lockout (5mL) Screw Top
• Catalog Number: AAM3000
• Company Name: GO MEDICAL INDUSTRIES PTY. LTD.
• Labeler DUNS: 757634266
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5bf486e0-a157-4afb-a08c-72c7bf92ac0a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCO	Inhaler, Nasal	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45564	Nasal inhaler	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09350902001379	GS1	Carton	20	In Commercial Distribution
Primary	09350902001362	GS1