Rondex CPR ISO-SHIELD (Made In USA) w poly bag & g 9500-G

GUDID 06343760095072

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: 06343760095072
• NIH Device Record Key: 513cf0c6-0aea-435b-b07e-409d422b6f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rondex CPR ISO-SHIELD (Made In USA) w poly bag & g
• Version Model Number: 9500-G (packaged in poly bag w gloves
• Catalog Number: 9500-G
• 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

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06343760095072 [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: 2016-10-30

Devices Manufactured by RONDEX PRODUCTS, INCORPORATED

• 00634376495506 - (HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case: 2023-05-22 The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when do
• 00634376495575 - (HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case: 2023-05-22 The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when do
• 00634376095577 - RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves: 2020-09-11 The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when do
• 00634376098073 - RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves: 2020-09-11 The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when d
• 00634376098509 - RONDEX CPR REDI-SHIELD (Made in USA) with key ring case: 2020-09-11 The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when d
• 00634376098578 - RONDEX CPR REDI-SHIELD (Made in USA) in key ring case with gloves: 2020-09-11 The RONDEX CPR REDI-SHIELD model #9850-G comes in a case with a key ring and gloves. It is a mouth-to-mask barrier device used
• 00634376095003 - Rondex CPR ISO-SHIELD (Made in USA) w poly bag: 2020-08-03 The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when do
• 00634376098004 - RONDEX CPR REDI-SHIELD (Made in USA) poly bag: 2020-07-17 The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when