| Primary Device ID | 06343760914021 |
| NIH Device Record Key | 8395db69-5556-4ffc-a81a-b01e3c2bb8ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rondex CPR Pocket Rescue Mask (Made in USA) #9140 |
| Version Model Number | 91402 (packaged in clamshell case) |
| Catalog Number | 91402 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com | |
| Phone | 815-226-0452 |
| request@rondex.com |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06343760914021 [Primary] |
| CBP | Valve, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-26 |
| 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 | 2020-08-03 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 |