ProVu

Basic Information

• Brand Name: ProVu
• Primary DI: 05055931111924
• Version / Model: 040-08-2120U
• Company Name: FLEXICARE MEDICAL LIMITED
• Labeler DUNS: 504406273
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-04
• Public Version: 1
• Public Version Date: 2024-03-12
• Public Version Status: New
• Public Device Record Key: d3570398-83f1-4f10-bad6-c25f625c84e8

Device Description

ProVu Single Use Video Laryngoscope Handle with Hyper Angulated Blade Size 2

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62763	Video intubation laryngoscope kit	A collection of video laryngoscopic devices intended to be used for various procedures on the airway and respiratory tract including intubation, lung dual-chamber positioning, suction, biopsy, drug administration and oxygen giving. It typically consists of a set of video intubation laryngoscope blades, a video intubation laryngoscope handle/monitor, a rigid non-bladed video intubation laryngoscope and a flexible video intubation laryngoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055931111924	GS1