RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves 9550-G

GUDID 00634376095577

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 MADE IN USA

RONDEX PRODUCTS, INCORPORATED

Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use
Primary Device ID00634376095577
NIH Device Record Key12f67073-c5e0-46c3-8913-2c1e9fec2cb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves
Version Model Number9550-G (w Key Ring/Belt Loop Case & Gloves)
Catalog Number9550-G
Company DUNS021435706
Company NameRONDEX PRODUCTS, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com
Phone815-226-0452
Emailgene@rondex.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100634376095577 [Primary]
GS106343760095577 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYMDevice, Cpr Assist

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-11
Device Publish Date2020-09-03

Devices Manufactured by RONDEX PRODUCTS, INCORPORATED

00634376495506 - (HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case2023-05-22 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 case2023-05-22 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 & Gloves2020-09-11The 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 MADE IN USA
00634376095577 - RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves2020-09-11 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 gloves2020-09-11 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 case2020-09-11 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 gloves2020-09-11 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 bag2020-08-03 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 bag2020-07-17 The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when
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