HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA)

GUDID 06343760498576

The HSI CPR REDI-SHIELD model #9850-G comes in a zipper case with a key ring and gloves. It is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve 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 ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. 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. REDI-SHIELD(TM) of Rondex MADE IN USA.

RONDEX PRODUCTS, INCORPORATED

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 06343760498576
• NIH Device Record Key: 764082e3-1ac4-4ae1-8138-d1328c4d41f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA)
• Version Model Number: 9850-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06343760498576 [Primary]

FDA Product Code

• LYM: Device, Cpr Assist

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: 2019-12-18
• Device Publish Date: 2019-12-10

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