Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit

Basic Information

• Brand Name: Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
• Primary DI: 00709078005381
• Version / Model: A9244
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-25
• Public Version: 2
• Public Version Date: 2019-12-24
• Public Version Status: Update
• Public Device Record Key: 10544e15-e0e3-4d67-9517-ea17660f8ee5

Device Description

48" Heated Humidified Transport Circuit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Expiration Date: Yes
• 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	00709078005381	GS1
Package	10709078005388	GS1		10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K904538	000