FDA.reportPublic FDA data

Rondex CPR Valve (Made in USA)

Primary DI
06343760020203
Brand
Rondex CPR Valve (Made in USA)
Company
RONDEX PRODUCTS, INCORPORATED
Model
2020 package in polybag
Catalog number
2020
Device description
The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA
Published
2016-10-31
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
K902299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902299000CPR VALVE (NON-REBREATHING) MODEL #9030Rondex Products, Inc.1990-10-26CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06343760020203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06343760020203063437600202036343760020203

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, single-useA non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.

Storage And Handling#

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