Ventlab

Basic Information

• Brand Name: Ventlab
• Primary DI: 10889483065716
• Version / Model: 4707
• Company Name: VENTLAB, LLC
• Labeler DUNS: 038305402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2019-10-21
• Public Version Status: Update
• Public Device Record Key: cb0d4105-a262-4f37-9dc0-6739a1ecc2da

Device Description

Adult 7ft Oral/Nasal Cannula

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: Yes
• 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: Yes
• 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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17614	Exhaled-gas oesophageal intubation detector, adult	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. It is used during adult intubation and is attached directly between the ET tube and the breathing device. It typically functions through colorimetric CO2 detection using an indicator paper that changes colour. A colour chart (e.g., attached to the device) permits interpretation into approximate CO2 concentration. It is used in healthcare facilities or in the field to evaluate oesophageal intubation, which if performed incorrectly, prevents patient ventilation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20889483065713	GS1	Box	25	In Commercial Distribution
Primary	10889483065716	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063813	000

Device Sizes

Type	Value	Unit	Text
Length	7	Feet

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: General Warehouse. Do not get wet.