Western/Scott Fetzer

Basic Information

• Brand Name: Western/Scott Fetzer
• Primary DI: B929MNDS6030
• Version / Model: MNDS-603
• Catalog Number: MNDS-603
• Company Name: WESTERN/SCOTT FETZER COMPANY
• Labeler DUNS: 148634731
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-29
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 86999eda-0a8a-4149-99c6-cfa733ec05cd

Device Description

E SIZE SYSTEM OXYTOTE DTE

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60970	Fixed medical gas cylinder regulator	A gas-regulating component 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. It typically includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B929MNDS6030	HIBCC

Customer Contacts

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