Ultra PC % Package U

Basic Information

• Brand Name: Ultra PC % Package U
• Primary DI: 00813830022643
• Version / Model: 36500-US
• Catalog Number: 36500-US
• Company Name: ACCUTRON, INC.
• Labeler DUNS: 088302096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-12
• Public Version: 3
• Public Version Date: 2023-09-04
• Public Version Status: Update
• Public Device Record Key: 98f77b0c-1cc0-41ce-a0cd-53457167f18b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
BSZ	Gas-Machine, Anesthesia	Anesthesiology	868.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44159	Oxygen/air/nitrous oxide breathing gas mixer	An independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813830022643	GS1

Premarket Submissions

Submission Number	Supplement Number
K970163	000