AccessGUDID - DEVICE: AirLife™ (10889483579251)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife™
Version or Model: 2812M-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2812M-10
Company Name: AIRLIFE

Primary DI Number: 10889483579251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use
Previous DI: 10190752113985

Device Description: AirLife™ Nasal ETCO2 Cannula, Adult with 7 foot O2 tube and 7 foot CO2 tube with male luer connector and 22 mm (I.D.) x 6 mm (O.D.) adaptor

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?
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120518	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: b4d0f056-63c9-4724-9843-ec20566da2a8
Public Version Date: April 17, 2025
Public Version Number: 2
DI Record Publish Date: February 19, 2025