MedPak

Basic Information

• Brand Name: MedPak
• Primary DI: 00810050862387
• Version / Model: MP2-009-09-A1B1C1D1
• Company Name: LIFEPORT, LLC
• Labeler DUNS: 556196210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-27
• Public Version: 1
• Public Version Date: 2023-04-04
• Public Version Status: New
• Public Device Record Key: 42275dd2-f410-493a-b1f5-4e133806c5d8

Device Description

MEDPAK ASSEMBLY, LOW PROFILE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTI	Compressor, Air, Portable	Anesthesiology	868.6250	2
BXO	Transducer, Gas Pressure	Anesthesiology	868.2900	1
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58008	Laboratory pump, vacuum	A mains electricity (AC-powered) pump designed for use in a laboratory to produce vacuum. It is typically used to support many laboratory activities/processes such as sample aspiration, separation, and drying. It has an electric motor typically connected to a rotating or membrane-type pump head that removes (sucks in) air to produce strong suction (vacuum). It is typically used to aspirate liquids from samples in various types of containers (e.g., microplates, test tubes), draw liquids through a filter, and create vacuum in containers.	No	Active
31278	Air/gas pressure transducer	A noninvasive electronic device designed to convert air or gas pressure signals into electrical signals for subsequent display or processing by a parent device (e.g., physiological data recorder, gastrointestinal motility analysis system). It may be a compact unit or included in an electrical cable, and receives pressure signals from connected pressure-measuring devices (e.g., urodynamic air-charged catheter, monitoring respiratory tubing).	No	Active
43438	Non-fixed medical gas cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.	No	Active
31253	Medical device air compressor	A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050862387	GS1

Customer Contacts

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