AccessGUDID - DEVICE: Argyle (10884527007066)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888162008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8888162008
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527007066
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: CPAP Nasal Cannula,Babies >1500 g

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:	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?
35202	Nasal oxygen cannula, CPAP	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 deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K811409	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Clothing Size,Large,N/A;

Device Record Status

Public Device Record Key: dfa12566-c4d7-4256-8461-56b18f07ab8f
Public Version Date: February 27, 2025
Public Version Number: 8
DI Record Publish Date: September 24, 2016