RONDEX CPR Pocket Rescue Mask (Made in USA) model 9120-PB

GUDID 06343760091234

The Rondex CPR Pocket Rescue Mask, Model #9120-PB, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There is a silicone

RONDEX PRODUCTS, INCORPORATED

Cardiopulmonary resuscitation mask, single-use
Primary Device ID06343760091234
NIH Device Record Key22f9b523-ca53-4e98-a3d9-9bdcf1a3110c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRONDEX CPR Pocket Rescue Mask (Made in USA) model
Version Model Number9120-PB (packaged in poly-bag)
Catalog Number9120-PB
Company DUNS021435706
Company NameRONDEX PRODUCTS, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com
Phone815-226-0452
Emailrequest@rondex.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS106343760091234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBPValve, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-17

On-Brand Devices [RONDEX CPR Pocket Rescue Mask (Made in USA) model ]

06343760091234The Rondex CPR Pocket Rescue Mask, Model #9120-PB, is for emergency mouth-to-mask ventilation on
06343760091203The Rondex CPR Pocket Rescue Mask, Model #9120, is for emergency mouth-to-mask ventilation on

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