NeoPod "T" AC to DC Power Supply Cable

Basic Information

• Brand Name: NeoPod "T" AC to DC Power Supply Cable
• Primary DI: 00709078001192
• Version / Model: 9401R
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 5
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 615f537f-b9e8-4b1b-90e5-0e0fe4f9860f

Device Description

AC to DC Power Supply Cable to provide 12VDC power to NeoPod "T" and Lava Bed Humidifier Cartridge.

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

GMDN Terms

Code	Name	Definition	Implantable	Status
37706	Ventilator breathing circuit, single-use	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10709078001199	GS1		1	In Commercial Distribution
Primary	00709078001192	GS1

Premarket Submissions

Submission Number	Supplement Number
K870173	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit