CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves

Primary DI
06343760195574
Brand
CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves
Company
RONDEX PRODUCTS, INCORPORATED
Model
CINTAS #9550-G w Black Key Ring/Belt Loop Case & G
Catalog number
171110
Device description
"The CINTAS 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"
Published
2016-10-06
Public version status
Update
Distribution status
Not 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
LYMDevice, Cpr Assist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYMDevice, Cpr Assist

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942671000CPR SHIELDRondex Products, Inc.1995-02-07CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06343760195574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06343760195574063437601955746343760195574

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseModel #9850 MKRS98502023-01-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634376095577RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & GlovesRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376098073RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and glovesRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376098509RONDEX CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376098578RONDEX CPR REDI-SHIELD (Made in USA) in key ring case with glovesRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376095003Rondex CPR ISO-SHIELD (Made in USA) w poly bagRONDEX PRODUCTS, INCORPORATEDLYM2020-07-26
00634376098004RONDEX CPR REDI-SHIELD (Made in USA) poly bagRONDEX PRODUCTS, INCORPORATEDLYM2020-07-09
00634376195574CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves RONDEX PRODUCTS, INCORPORATEDLYM2020-07-07
06343760498576HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA)RONDEX PRODUCTS, INCORPORATEDLYM2019-12-10
06343760098073RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and glovesRONDEX PRODUCTS, INCORPORATEDLYM2017-07-20
06343760098516RONDEX CPR REDI-SHIELD (Made in USA) in zipper key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760395509EMS SAFETY CPR ISO-SHIELD (Made in USA) w key ring/belt loop caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760398500EMS SAFETY CPR REDI-SHIELD (Made in USA) with key ring flap closure caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760398517EMS SAFETY CPR REDI-SHIELD (Made in USA) with zipper key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760098004RONDEX CPR REDI-SHIELD (Made in USA) in poly bagRONDEX PRODUCTS, INCORPORATEDLYM2016-11-01
06343760098509RONDEX CPR REDI-SHIELD (Made in USA) in key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2016-11-01
06343760098578RONDEX CPR REDI-SHIELD (Made in USA) w key ring case & gloves RONDEX PRODUCTS, INCORPORATEDLYM2016-11-01
06343760095072Rondex CPR ISO-SHIELD (Made In USA) w poly bag & glovesRONDEX PRODUCTS, INCORPORATEDLYM2016-10-30
06343760095003Rondex CPR ISO-SHIELD (Made In USA) w poly bag RONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760095508Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop CaseRONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760095577Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop Case & GlovesRONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760295571CINTAS CPR ISO-SHIELD (Made In USA) w Orange Key Ring/Belt Loop Case & GlovesRONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
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17540195055060Rescue Breather CPR Protective barrierO-Two Medical Technologies IncLYM2016-09-23