LITEAIRE

Basic Information

• Brand Name: LITEAIRE
• Primary DI: 00383480000495
• Version / Model: 1303
• Catalog Number: 1303, 1304, 1306
• Company Name: THAYER MEDICAL CORPORATION
• Labeler DUNS: 626238844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 7
• Public Version Date: 2019-09-16
• Public Version Status: Update
• Public Device Record Key: 91638060-dc53-4456-879c-333760ed6b35

Device Description

DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER: CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT. CATALOG NUMBER 1304 IS 1 DISPENSER BOX CONTAINING 25 INDIVIDUAL LITEAIRE UNITS IN A SHIPPING CONTAINER. CATALOG NUMBER 1306 IS 4 DISPENSER BOXES, EACH CONTAINING 25 LITEAIRE UNITS (100 LITEAIRE UNITS IN TOTAL) IN A SHIPPING CONTAINER.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38018	Medicine chamber spacer, reusable	A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40383480000493	GS1	CASE	25	In Commercial Distribution
Primary	00383480000495	GS1
Package	30383480000496	GS1	CASE	4	In Commercial Distribution
Package	10383480000492	GS1	INNER PACK	25	In Commercial Distribution
Package	20383480000499	GS1	CASE	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]