(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case MKIS 9550

GUDID 00634376495506

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. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex Products, Inc. MADE IN USA

RONDEX PRODUCTS, INCORPORATED

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 00634376495506
• NIH Device Record Key: 71ad52fe-dacc-477d-a403-d0caef1ed0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: (HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case
• Version Model Number: Model 9550
• Catalog Number: MKIS 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
• 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
• 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	00634376495506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942671

FDA Product Code

• CBP: Valve, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-22
• Device Publish Date: 2023-05-12

On-Brand Devices [(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case]

• 00634376495575: The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct
• 00634376495506: The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct