GENTEC®

Basic Information

• Brand Name: GENTEC®
• Primary DI: 06970966663929
• Version / Model: FM197A -70L-HS Series
• Company Name: GENTEC(SHANGHAI)CORPORATION
• Labeler DUNS: 545287658
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: eeff757f-7816-45d5-b8bf-55816d0a3b43
• Distribution End Date: 2023-06-21

Device Description

FM197A Series 70L flowmeter with hose and accessories, oxygen.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	868.2340	1
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	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
42039	Oxygen low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed oxygen (O2) from an O2 terminal unit or O2 cylinder to a medical device that functions with O2 (e.g., ventilators, anaesthesia unit, analgesia unit, and other O2 dependent respiratory device). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970966663929	GS1