AccessGUDID - DEVICE: NeoPod "T" AC to DC Power Supply Cable (00709078001192)

GUDID

Device Identifier (DI) Information

Brand Name: NeoPod "T" AC to DC Power Supply Cable
Version or Model: 9401R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078001192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K870173	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 615f537f-b9e8-4b1b-90e5-0e0fe4f9860f
Public Version Date: October 24, 2022
Public Version Number: 5
DI Record Publish Date: December 15, 2016