MedSource Regulator

Basic Information

• Brand Name: MedSource Regulator
• Primary DI: 00840155400450
• Version / Model: MS-28310
• Catalog Number: Not Applicable
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Labeler DUNS: 041674552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: e288ffb7-9d45-4f4a-81a4-94d383a0a65e

Device Description

O2 Regulator (Brass Core, 2 DISS) 0-25

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: 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
Package	00840155400467	GS1	Case	20	In Commercial Distribution
Primary	00840155400450	GS1