SüpeVac – Portable Single Use Hand-Held Suction Device

Basic Information

• Brand Name: SüpeVac – Portable Single Use Hand-Held Suction Device
• Primary DI: 00860004198857
• Version / Model: CM200
• Catalog Number: CM200
• Company Name: GMMI SDN. BHD.
• Labeler DUNS: 865757421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-23
• Public Version: 1
• Public Version Date: 2025-06-02
• Public Version Status: New
• Public Device Record Key: 701139ce-f311-46dd-a917-8e41a7a55430

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	Bottle, Collection, Vacuum	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47367	Emergency airway clearance suction system, pneumatic	A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart), by means of suction generated from a compressed gas supply (the Venturi principle). It includes a pneumatic suction regulator which controls the degree of negative pressure for aspiration, a portable supply of compressed gas (e.g., cylinder of air or oxygen), collection containers, tubing, microbial/hydrophobic filters, and patient contact devices (e.g., handpiece/tip, mask).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860004198854	GS1	Carton	20	In Commercial Distribution
Primary	00860004198857	GS1

Customer Contacts

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