Thayer Medical LiteAire Dual-Valved, Collapsible MDI Holding Chamber
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- LITEAIRE EUDAMEDFDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- LiteAire Collapsible Dual Valved Holding Chamber EUDAMEDLITEAIRE ENHANCED - DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER (ENHANCED): CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT (SOLD IN BULK 25 AND 400 QUANTITIES WITHOUT A DISPENSER BOX IN A SHIPPING CONTAINER). 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. FDA UDI
- Model / Reference
- 1303 EUDAMEDFDA UDI
- Description
- LITEAIRE ENHANCED - DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER (ENHANCED): CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT (SOLD IN BULK 25 AND 400 QUANTITIES WITHOUT A DISPENSER BOX IN A SHIPPING CONTAINER). 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. FDA UDI
Identifiers
- Catalog Number
- 1303, 1304, 1306 FDA UDI
- Primary DI / UDI-DI
- 00383480000006 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00383480000006 EUDAMED
- 510(k) Number
- K160109 FDA 510(k)
- FDA Product Code
- NVP FDA 510(k)FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Medicine chamber spacer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Thayer Medical LiteAire Dual-Valved, Collapsible MDI Holding Chamber is a Holding Chamber, Direct Patient Interface (per FDA classification 868.5630) designed to improve the administration of metered-dose inhaler (MDI) medications. Its dual-valved, collapsible paperboard construction enhances convenience and medication delivery efficiency by reducing dead-space volume and allowing for easy storage and transport.
This device is intended for single-use in respiratory care settings, including anesthesia and pediatric applications, as indicated by its advisory committee classification. Supplied in a collapsible format, it requires no sterilization and is packaged in boxes of 25 units. The device holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD). No MRI safety information or reusable components are specified.
Frequently asked questions
What clinical settings is this holding chamber designed for, and how does its dual-valved design benefit patients?
The Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is specifically designed for use in respiratory care settings, including anesthesia and pediatric applications. Its dual-valved, collapsible paperboard construction reduces dead-space volume, which improves medication delivery efficiency by minimizing wasted medication. This design also enhances convenience, as the chamber can be easily stored and transported without requiring sterilization.
Is this device reusable, or is it intended for single-use? How is it packaged and supplied?
This device is intended for single-use only in clinical settings. It is supplied in a collapsible format, packaged in boxes containing 25 units per box, eliminating the need for sterilization or reprocessing. The paperboard construction ensures it remains functional for one use before disposal.
Does this holding chamber require any special storage conditions, and how does its collapsible design affect usability?
The LiteAire chamber does not require refrigeration or specialized storage conditions—it can be stored at room temperature. Its collapsible design makes it compact for transport and easy to store when not in use, while still providing a sealed interface for MDI medications when expanded for patient use.
What regulatory pathways does this device follow, and how does its classification impact its use?
The device holds FDA 510(k) clearance under classification 868.5630 (Holding Chambers, Direct Patient Interface) and complies with the Medical Device Directive (MDD). Its classification as a Class II device (via the FDA’s advisory committee, AN) reflects its role in improving medication delivery efficiency, particularly in anesthesia and pediatric care, without requiring invasive procedures.
Are there any size variations or models available for this holding chamber, or is it a single standardized unit?
The provided data does not specify multiple size variations or distinct models for the LiteAire Dual-valved Holding Chamber. It is described as a single standardized unit designed for MDI medications, with no mention of customizable volumes or additional configurations. Always verify the exact specifications with the manufacturer if size requirements are critical for your application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Thayer Medical LiteAire® MDI holding Chamber, Thayer Medical | Products for Respiratory Care | MDI Holding Chambers ..., LiteAire - Timik Group, LiteAire MDI Holding Chamber, 25/Box - School Health
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160109 | Class II | Active |
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Manufacturer
- Manufacturer
- Thayer Medical Corporation
Sources (3)
- FDA 510(k) K160109 24 fields · synced Oct 6, 2026
- FDA UDI 52695e35-c1ed-4ae0-85d6-3e849e221165 35 fields · synced May 30, 2026
- EUDAMED 735afaac-80fd-4212-a13e-289c2eb97529 61 fields · synced Jul 25, 2026