ProCure

Basic Information

• Brand Name: ProCure
• Primary DI: 10840330704233
• Version / Model: 1006349
• Catalog Number: 1006349
• Company Name: Twin Med, LLC
• Labeler DUNS: 107071289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-25
• Public Version: 3
• Public Version Date: 2026-04-08
• Public Version Status: Update
• Public Device Record Key: 97e9c6a4-14ce-4692-883e-9b64cad46ac4

Device Description

Suction Catheter Kit 1-Pair Disposable Vinyl Gloves, 1- Mini Tray Sterile 16FR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10840330704233	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	16	French
Outer Diameter	5.3	Millimeter
Length	55	Centimeter