AccessGUDID - DEVICE: Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop Case (06343760095508)

GUDID

Device Identifier (DI) Information

Brand Name: Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop Case
Version or Model: 9550 (w Key Ring/Belt Loop Case
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9550
Company Name: RONDEX PRODUCTS, INCORPORATED

Primary DI Number: 06343760095508
Issuing Agency: GS1
Commercial Distribution End Date: July 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021435706 *Terms of Use

Device Description: The Rondex 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 Products, Inc. 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":	No
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
LYM	Device, Cpr Assist

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942671	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 -40 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 27895033-4bcc-46f7-aae4-e81d4cfa9c36
Public Version Date: July 06, 2020
Public Version Number: 4
DI Record Publish Date: October 06, 2016