PRO-TECH

Basic Information

• Brand Name: PRO-TECH
• Primary DI: 00606959032170
• Version / Model: CANNULA
• Catalog Number: 1083806
• 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: 4
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 037fe791-189b-4ddd-8419-f7b5603b2259
• Distribution End Date: 9999-12-31

Device Description

NASAL CANNULA, ADULT, FILTERLESS

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNR	VENTILATORY EFFORT RECORDER	Anesthesiology	868.2375	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	30606959032171	GS1	Multipack	10	Not in Commercial Distribution	1999-12-31
Primary	00606959032170	GS1
Package	40606959032178	GS1	Multipack	60	Not in Commercial Distribution	1999-12-31

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982293	000