Ventlab

Basic Information

• Brand Name: Ventlab
• Primary DI: 10889483089637
• Version / Model: br304-i
• Company Name: VENTLAB, LLC
• Labeler DUNS: 038305402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-01
• Public Version: 3
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: b7869efb-60bd-4a89-b959-6f2c48145a5f

Device Description

Anti-Static Spacer, Rigid w/ Intersurgical Mask Size 4

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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10226	Atomizer, non-ventilatory	A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20889483089634	GS1	Box	20	In Commercial Distribution
Primary	10889483089637	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	22	Millimeter

Storage Conditions

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