(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 table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981169000RONDEX CPR ISO-SHIELDRondex Products, Inc.1998-05-19CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634376498507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634376498507006343764985076343764985070634376498507

GMDN Terms#

Term, Definition table
TermDefinition
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, Email table
PhoneEmail
815-226-0452request@rondex.com

Regulatory Flags#

DUNS number
021435706
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634376495506(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring caseModel 9550MKIS 95502023-05-12
00634376495575(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring caseModel 9550-G50112023-05-12
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves Model #9850-G MKRS9850G2023-01-02
00634376095577RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves9550-G (w Key Ring/Belt Loop Case & Gloves)9550-G2020-09-03
00634376098073RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves9800-G (package in poly bag with gloves)9800-G2020-09-03
00634376098509RONDEX CPR REDI-SHIELD (Made in USA) with key ring case9850 (Packaged in key ring case)98502020-09-03
00634376098578RONDEX CPR REDI-SHIELD (Made in USA) in key ring case with gloves9850-G (packaged in key ring case) 9850-G 2020-09-03
00634376095003Rondex CPR ISO-SHIELD (Made in USA) w poly bag9500 (packaged in poly bag)95002020-07-26
00634376098004RONDEX CPR REDI-SHIELD (Made in USA) poly bag9800 (packaged in poly bag)98002020-07-09
00634376195574CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves CINTAS #9550-G w Black Key Ring/Belt Loop Case & G1711102020-07-07
06343760098509RONDEX CPR REDI-SHIELD (Made in USA) in key ring case9850 (packaged in key ring case)98502016-11-01
06343760020203Rondex CPR Valve (Made in USA)2020 package in polybag20202016-10-31
06343760040409RONDEX CPR ISO-VALVE (Made in USA) 4040 (packaged in polybag)40402016-11-01
06343760091203Rondex CPR Pocket Rescue Mask (Made in USA) model #91209120 (packaged in a plastic clamshell case)91202016-11-26
06343760091234RONDEX CPR Pocket Rescue Mask (Made in USA) model #9120-PB9120-PB (packaged in poly-bag)9120-PB2017-11-17
06343760091432RONDEX CPR POCKET RESCUE MASK w poly bag (Made in USA)9140-PB (packaged in poly-bag)9140-PB2017-07-15
06343760095072Rondex CPR ISO-SHIELD (Made In USA) w poly bag & gloves9500-G (packaged in poly bag w gloves9500-G2016-10-30
06343760095577Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop Case & Gloves9550-G (w Key Ring/Belt Loop Case & Gloves)9550-G2016-10-06
06343760098004RONDEX CPR REDI-SHIELD (Made in USA) in poly bag9800 (packaged in poly bag)98002016-11-01
06343760098073RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves9800-G (packaged in poly bag with gloves)9800-G2017-07-20

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