AccessGUDID - DEVICE: AirLife™ (10889483570388)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife™
Version or Model: 001505
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001505
Company Name: AIRLIFE

Primary DI Number: 10889483570388
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use
Previous DI: 10190752145375

Device Description: AirLife™ Tee adapter With One Arm 22 mm I.D., One Arm 22 mm O.D., 18 mm I.D. Base with Mouthpiece

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:	Yes
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?
35457	Benchtop nebulizer, non-heated	An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	Connector, Airway (Extension)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: bb9a72a9-4fe6-49ec-95d8-e66d131f672a
Public Version Date: April 17, 2025
Public Version Number: 2
DI Record Publish Date: February 20, 2025