DoubleCHEK

Basic Information

• Brand Name: DoubleCHEK
• Primary DI: 05060692190033
• Version / Model: DC-1001
• Company Name: ENTERAL ACCESS TECHNOLOGIES LTD
• Labeler DUNS: 223906575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-06
• Public Version: 1
• Public Version Date: 2024-10-14
• Public Version Status: New
• Public Device Record Key: 34e3811d-725a-48da-acb3-1fb29f561d5e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15164	pH meter IVD	A manual, semi-automated, or automated instrument intended to be used for the qualitative and/or quantitative in vitro determination of the pH of a clinical specimen (i.e., its degree of acidity or alkalinity) by measuring hydrogen ion concentration.	No	Active
17614	Exhaled-gas oesophageal intubation detector	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing exhaled carbon dioxide (CO2) during airway management to confirm correct intubation for appropriate ventilation; it may additionally be intended to confirm placement/ventilation when using a laryngeal mask airway and/or face mask. It is intended to be connected to the intubation device and/or ventilator breathing circuit (e.g., the T-piece connector or hose). It typically functions through colorimetric CO2 detection using a chemical reaction based and/or paper indicator that changes colour based on the approximate CO2 concentration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060692190040	GS1		10	In Commercial Distribution
Primary	05060692190033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212316	000