| Primary Device ID | 00634376095003 |
| NIH Device Record Key | 073b003a-3a4d-4431-b985-125ba31019c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rondex CPR ISO-SHIELD (Made in USA) w poly bag |
| Version Model Number | 9500 (packaged in poly bag) |
| Catalog Number | 9500 |
| 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 |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com | |
| Phone | 915-226-0452 |
| request@rondex.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00634376095003 [Primary] |
| GS1 | 06343760095003 [Previous] |
| LYM | Device, Cpr Assist |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-03 |
| Device Publish Date | 2020-07-26 |
| 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 | 2020-08-03The 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 |
| 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 |