Ventlab

Basic Information

• Brand Name: Ventlab
• Primary DI: 10889483160909
• Version / Model: VR0900-40
• Catalog Number: VR0900-40
• Company Name: VENTLAB, LLC
• Labeler DUNS: 038305402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-02
• Public Version: 1
• Public Version Date: 2023-06-12
• Public Version Status: New
• Public Device Record Key: d831a1ff-9f1d-464e-9d99-9c61638a1b11

Device Description

Small Neonate Premium ERGO mask

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: Yes
• PM Exempt: Yes
• 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
BSJ	MASK, GAS, ANESTHETIC	Anesthesiology	868.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46232	Anaesthesia face mask, single-use	A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889483160909	GS1

Customer Contacts

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