FDA.reportPublic FDA data

Rondex CPR Pocket Rescue Mask (Made in USA) #9140

Primary DI
06343760091401
Brand
Rondex CPR Pocket Rescue Mask (Made in USA) #9140
Company
RONDEX PRODUCTS, INCORPORATED
Model
9140 (packaged in clamshell case)
Catalog number
9140
Device description
The Rondex CPR Pocket Rescue Mask, Model #9140, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA
Published
2016-11-26
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
CBPValve, Non-Rebreathing

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943761000NON-BREATHING VALVERondex Products, Inc.1994-11-10CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06343760091401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06343760091401063437600914016343760091401

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 Temperature36 Degrees Fahrenheit104 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
Expiration date on label
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

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Primary DI, Brand, Company table
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00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
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