AccessGUDID - DEVICE: RONDEX CPR POCKET RESCUE MASK w poly bag (Made in USA) (06343760091432)

GUDID

Device Identifier (DI) Information

Brand Name: RONDEX CPR POCKET RESCUE MASK w poly bag (Made in USA)
Version or Model: 9140-PB (packaged in poly-bag)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9140-PB
Company Name: RONDEX PRODUCTS, INCORPORATED

Primary DI Number: 06343760091432
Issuing Agency: GS1
Commercial Distribution End Date: July 06, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021435706 *Terms of Use

Device Description: The Rondex CPR Pocket Rescue Mask, Model #9140-PB, 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 poly-bag along with the valve. Made In USA

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61326	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBP	Valve, Non-Rebreathing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943761	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c353c2a6-87d9-4d20-ba93-012e3792b5aa
Public Version Date: July 07, 2020
Public Version Number: 4
DI Record Publish Date: July 15, 2017