TEC-505-1AS

Basic Information

• Brand Name: TEC-505-1AS
• Primary DI: 00853061006715
• Version / Model: T115P10
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: 1450aeaa-12c9-4333-9655-89be4c27bb3d
• Distribution End Date: 2019-05-06

Device Description

Oxygen Sensor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	868.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13538	Respiratory oxygen sensor	A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853061006715	GS1

Premarket Submissions

Submission Number	Supplement Number
K963415	000