AccessGUDID - DEVICE: RONDEX CPR ISO-VALVE (Made in USA) (06343760040409)

GUDID

Device Identifier (DI) Information

Brand Name: RONDEX CPR ISO-VALVE (Made in USA)
Version or Model: 4040 (packaged in polybag)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4040
Company Name: RONDEX PRODUCTS, INCORPORATED

Primary DI Number: 06343760040409
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 ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask. It contains a total of two (2) silicone valves to help isolate the rescuer from the patient's breath. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA (ISO-VALVE(TM) of Rondex Products, Inc.)

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?
60657	Non-rebreathing valve, single-use	A 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.	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
Storage Environment Temperature: between -40 and 122 Degrees Fahrenheit
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: ec344df9-9a31-462b-ac5e-4c3e9ab7e769
Public Version Date: July 07, 2020
Public Version Number: 4
DI Record Publish Date: November 01, 2016