ProVu Video Stylet

Basic Information

• Brand Name: ProVu Video Stylet
• Primary DI: 05055788776260
• Version / Model: 038-995-070U
• Catalog Number: 038-995-070U
• Company Name: FLEXICARE MEDICAL LIMITED
• Labeler DUNS: 504406273
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-30
• Public Version: 1
• Public Version Date: 2025-06-09
• Public Version Status: New
• Public Device Record Key: 30f20f67-0cc8-4d74-a409-3a49f7cb1fba

Device Description

ProVu Video Stylet with Reinforced ET Tube Size 7.0

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: MR Unsafe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2
BSR	Stylet, Tracheal Tube	Anesthesiology	868.5790	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64758	Video-intubation endotracheal tube	A hollow cylinder intended to be inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The tube includes a disposable steerable stylet with an integrated video camera intended to be connected to an appropriate monitor to allow endoscopic-like video assistance during intubation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055788776260	GS1