AccessGUDID - DEVICE: AEROCHAMBER mini Holding Chamber (62860875010029)

GUDID

Device Identifier (DI) Information

Brand Name: AEROCHAMBER mini Holding Chamber
Version or Model: 875010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 87594010
Company Name: Trudell Medical International

Primary DI Number: 62860875010029
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 203298203 *Terms of Use

Device Description: AEROCHAMBER mini Holding Chamber

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":	No
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?
35122	Metered dose inhaler	A hand-held device designed to administer a pre-measured dose of aerosolized medication directly into the mouth of a patient. It typically consists of a shaped plastic holder with integrated mouthpiece into which a pressurized metal canister containing the solution or suspension of medicine is placed. Commonly known as a metered dose inhaler (MDI), aerosol inhaler or puffer, it is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. A medicine chamber spacer may be attached to this device to facilitate its use by small children (enables the slow inhalation of the medicine). This is a reusable device intended for single-patient use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090065	000

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: 5651120a-ed10-4943-82a4-eeea5699d8cd
Public Version Date: April 23, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2016