Rondex CPR Valve (Made in USA)

Basic Information

• Brand Name: Rondex CPR Valve (Made in USA)
• Primary DI: 06343760020203
• Version / Model: 2020 package in polybag
• Catalog Number: 2020
• Company Name: RONDEX PRODUCTS, INCORPORATED
• Labeler DUNS: 021435706
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-31
• Public Version: 4
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 67c608e9-ce87-406a-bc5b-e15d5747bdbd
• Distribution End Date: 2020-07-06

Device Description

The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60657	Non-rebreathing valve, single-use	A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06343760020203	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K902299	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -40 – 122 Degrees Fahrenheit