RONDEX CPR Pocket Rescue Mask (Made in USA) model 9120-PB

GUDID 06343760091234

The Rondex CPR Pocket Rescue Mask, Model #9120-PB, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There is a silicone

RONDEX PRODUCTS, INCORPORATED

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 06343760091234
• NIH Device Record Key: 22f9b523-ca53-4e98-a3d9-9bdcf1a3110c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RONDEX CPR Pocket Rescue Mask (Made in USA) model
• Version Model Number: 9120-PB (packaged in poly-bag)
• Catalog Number: 9120-PB
• 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: true
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06343760091234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902299

FDA Product Code

• CBP: Valve, Non-Rebreathing

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: 2017-11-17

On-Brand Devices [RONDEX CPR Pocket Rescue Mask (Made in USA) model ]

• 06343760091234: The Rondex CPR Pocket Rescue Mask, Model #9120-PB, is for emergency mouth-to-mask ventilation on
• 06343760091203: The Rondex CPR Pocket Rescue Mask, Model #9120, is for emergency mouth-to-mask ventilation on