(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring case
- Primary DI
- 00634376498507
- Brand
- (HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring case
- Company
- RONDEX PRODUCTS, INCORPORATED
- Model
- Model #9850
- Catalog number
- MKRS9850
- Device description
- "The Rondex CPR REDI-SHIELD 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. The REDI-SHIELD with a bite block advantage is very compact which makes it ideal for key ring cases. 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."
- Published
- 2023-01-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| CBP | Valve, Non-Rebreathing |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | Anesthesiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K981169 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00634376498507 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00634376498507 | 00634376498507 | 634376498507 | 0634376498507 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cardiopulmonary resuscitation mask, single-use | "A flexible, form-shaped device that is placed over a patient's mouth to administer ""mouth-to-mask"" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace ""mouth-to-mouth"" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device." |
Contacts#
| Phone | |
|---|---|
| 815-226-0452 | request@rondex.com |
Regulatory Flags#
- DUNS number
- 021435706
- Device count
- 1
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00634376495506 | (HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case | Model 9550 | MKIS 9550 | 2023-05-12 |
| 00634376495575 | (HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case | Model 9550-G | 5011 | 2023-05-12 |
| 00634376498576 | (HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves | Model #9850-G | MKRS9850G | 2023-01-02 |
| 00634376095577 | RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves | 9550-G (w Key Ring/Belt Loop Case & Gloves) | 9550-G | 2020-09-03 |
| 00634376098073 | RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves | 9800-G (package in poly bag with gloves) | 9800-G | 2020-09-03 |
| 00634376098509 | RONDEX CPR REDI-SHIELD (Made in USA) with key ring case | 9850 (Packaged in key ring case) | 9850 | 2020-09-03 |
| 00634376098578 | RONDEX CPR REDI-SHIELD (Made in USA) in key ring case with gloves | 9850-G (packaged in key ring case) | 9850-G | 2020-09-03 |
| 00634376095003 | Rondex CPR ISO-SHIELD (Made in USA) w poly bag | 9500 (packaged in poly bag) | 9500 | 2020-07-26 |
| 00634376098004 | RONDEX CPR REDI-SHIELD (Made in USA) poly bag | 9800 (packaged in poly bag) | 9800 | 2020-07-09 |
| 00634376195574 | CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves | CINTAS #9550-G w Black Key Ring/Belt Loop Case & G | 171110 | 2020-07-07 |
| 06343760098509 | RONDEX CPR REDI-SHIELD (Made in USA) in key ring case | 9850 (packaged in key ring case) | 9850 | 2016-11-01 |
| 06343760020203 | Rondex CPR Valve (Made in USA) | 2020 package in polybag | 2020 | 2016-10-31 |
| 06343760040409 | RONDEX CPR ISO-VALVE (Made in USA) | 4040 (packaged in polybag) | 4040 | 2016-11-01 |
| 06343760091203 | Rondex CPR Pocket Rescue Mask (Made in USA) model #9120 | 9120 (packaged in a plastic clamshell case) | 9120 | 2016-11-26 |
| 06343760091234 | RONDEX CPR Pocket Rescue Mask (Made in USA) model #9120-PB | 9120-PB (packaged in poly-bag) | 9120-PB | 2017-11-17 |
| 06343760091432 | RONDEX CPR POCKET RESCUE MASK w poly bag (Made in USA) | 9140-PB (packaged in poly-bag) | 9140-PB | 2017-07-15 |
| 06343760095072 | Rondex CPR ISO-SHIELD (Made In USA) w poly bag & gloves | 9500-G (packaged in poly bag w gloves | 9500-G | 2016-10-30 |
| 06343760095577 | Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop Case & Gloves | 9550-G (w Key Ring/Belt Loop Case & Gloves) | 9550-G | 2016-10-06 |
| 06343760098004 | RONDEX CPR REDI-SHIELD (Made in USA) in poly bag | 9800 (packaged in poly bag) | 9800 | 2016-11-01 |
| 06343760098073 | RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves | 9800-G (packaged in poly bag with gloves) | 9800-G | 2017-07-20 |
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| 00634376498576 | (HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves | RONDEX PRODUCTS, INCORPORATED | CBP | 2023-01-02 |
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