Manifold

Basic Information

• Brand Name: Manifold
• Primary DI: 00817770023913
• Version / Model: 0-1 and 0-15 LPM Thorpe
• Catalog Number: R220P15-001
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 1
• Public Version Date: 2020-12-17
• Public Version Status: New
• Public Device Record Key: 418c88e3-7431-481b-8f9c-54d7b049f9f8

Device Description

Manifold, 0-1 and 0-15 LPM Dual Thorpe Flowmeter with DISS Fitting

Device Characteristics

• Single Use: No
• 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: 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
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	868.2340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61365	Medical gas flowmeter, Thorpe tube	A device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817770023913	GS1