AccessGUDID - DEVICE: LITEAIRE (00383480000006)

GUDID

Device Identifier (DI) Information

Brand Name: LITEAIRE
Version or Model: 1303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1303, 1304, 1306
Company Name: THAYER MEDICAL CORPORATION

Primary DI Number: 00383480000006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626238844 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NVP	Holding Chambers, Direct Patient Interface

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 52695e35-c1ed-4ae0-85d6-3e849e221165
Public Version Date: September 18, 2024
Public Version Number: 2
DI Record Publish Date: May 09, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10383480000003	25	00383480000006	In Commercial Distribution	Inner Pack
20383480000000	1	10383480000003	In Commercial Distribution	Case
30383480000007	4	10383480000003	In Commercial Distribution	Case
40383480000004	400	00383480000006	In Commercial Distribution	Bulk
50383480000001	25	00383480000006	In Commercial Distribution	Bulk