Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Bel 9550

GUDID 06343760095508

The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Lar

RONDEX PRODUCTS, INCORPORATED

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 06343760095508
• NIH Device Record Key: 27895033-4bcc-46f7-aae4-e81d4cfa9c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Bel
• Version Model Number: 9550 (w Key Ring/Belt Loop Case
• Catalog Number: 9550
• Company DUNS: 021435706
• Company Name: RONDEX PRODUCTS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com
• Phone: 815-226-0452
• Email: request@rondex.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06343760095508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942671

FDA Product Code

• LYM: Device, Cpr Assist

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-06

On-Brand Devices [Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Bel]

• 06343760095577: The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct
• 06343760095508: The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct