Pro-Flow

Basic Information

• Brand Name: Pro-Flow
• Primary DI: 00606959032330
• Version / Model: PRO-FLOW PLUS MULTIPURPOSE ORAL CANNULA, PEDIATRIC, REGULAR
• Catalog Number: P1365
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 5
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 62be1b2d-ba32-4d99-a456-5af1b388ccd4

Device Description

PRO-FLOW PLUS MULTIPURPOSE ORAL CANNULA, PEDIATRIC, REGULAR

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30606959032331	GS1	Multipack	30	Not in Commercial Distribution	1999-12-31
Primary	00606959032330	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053063	000