Anapod Controller

Basic Information

• Brand Name: Anapod Controller
• Primary DI: 00709078001161
• Version / Model: A2003R
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 665f5666-a57e-4c50-860d-467b1032d16b

Device Description

Anapod Controller

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: Yes
• 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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35872	Airway temperature monitoring system	An assembly of devices typically used bedside to continuously measure the temperature at a specific point along a ventilation airway (e.g., inspiratory limb, Y-piece). It typically includes a temperature sensor, a transducer, a cable, and an electronic unit with a display and alarms (audible and/or visual). The system provides real-time information on the temperature of the gases supplied to patients under assisted ventilation, particularly when a heated humidifier is incorporated into the inspiratory line of a patient's breathing circuit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00709078001161	GS1

Premarket Submissions

Submission Number	Supplement Number
K870173	000