Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884527007103
• Version / Model: 8888163030
• Catalog Number: 8888163030
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 038c64a9-c0d2-42c7-a081-26c48dc9da70

Device Description

CPAP Nasal Cannula with Bonnet,Babies 1000 g >1500 g

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884527007100	GS1	CASE	10	In Commercial Distribution
Primary	10884527007103	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K811409	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Clothing Size,Small,N/A;

Storage Conditions

• Type: Special Storage Condition, Specify