MIDAS REX

Basic Information

• Brand Name: MIDAS REX
• Primary DI: 00763000080051
• Version / Model: PA200
• Company Name: MEDTRONIC POWERED SURGICAL SOLUTIONS
• Labeler DUNS: 098308849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-08
• Public Version: 1
• Public Version Date: 2019-06-17
• Public Version Status: New
• Public Device Record Key: 138e8e76-c41b-4f35-a906-c71021593bd0

Device Description

ACCY PA200 MIDAS REX REGULATOR DISS

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: No
• Has Serial Number: Yes
• 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
BXH	GAUGE, GAS PRESSURE, CYLINDER/PIPELINE	Anesthesiology	868.2610	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47860	Surgical air pipeline regulator	A reduction valve designed to lower high and variable gas pressure in a pipeline intended for surgical applications (e.g., to drive surgical power tools) to a lower and constant working pressure, typically 3 - 12 bar. It consists of a housing containing a single- or dual-stage regulator used to regulate the surgical air, connectors (these may be permanent or quick connectors), and a pressure gauge; it may include an integral filter to remove possible contaminants, sometimes with a glass bowl for the collection of oil deposits and for observation. It is typically made of metal and synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000080051	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183515	000