AccessGUDID - DEVICE: Inspirachamber with InspiraMask (Large) (00852367007013)

GUDID

Device Identifier (DI) Information

Brand Name: Inspirachamber with InspiraMask (Large)
Version or Model: IC-IML-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSPIRX, INC

Primary DI Number: 00852367007013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967174850 *Terms of Use

Device Description: InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit

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: 1f75d8ef-96b9-4932-a441-ceff33f2322d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 18, 2017