N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04710810105067
• Version / Model: B025
• Catalog Number: XRL0015
• Company Name: GALEMED CORPORATION
• Labeler DUNS: 656854379
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-17
• Public Version: 2
• Public Version Date: 2026-03-04
• Public Version Status: Update
• Public Device Record Key: 70338637-ee6d-4a24-bbc0-73bf7ada7cf4

Device Description

nProng, #5

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: 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	24710810105061	GS1	Box	5	In Commercial Distribution
Primary	04710810105067	GS1

Premarket Submissions

Submission Number	Supplement Number
K110471	000