(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case 5011

GUDID 00634376495575

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

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Primary Device ID00634376495575
NIH Device Record Key74a579bd-4a22-46f2-8791-024e24e3605b
Commercial Distribution StatusIn Commercial Distribution
Brand Name(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case
Version Model NumberModel 9550-G
Catalog Number5011
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@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
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
GS100634376495575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBPValve, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-22
Device Publish Date2023-05-12

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

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