HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 14026704659149
• Version / Model: IPN913709
• Catalog Number: 1694
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-17
• Public Version: 5
• Public Version Date: 2022-10-26
• Public Version Status: Update
• Public Device Record Key: d4bd525e-e2f2-475d-b51c-8f9029bc3693

Device Description

INFANT NASAL CPAP CANNULA,SIZE 4

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: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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	24026704659146	GS1	Case	10	Not in Commercial Distribution	2022-10-25
Primary	14026704659149	GS1
Previous	04026704595310	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K871157	000