AccessGUDID - DEVICE: Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit (00709078004490)

GUDID

Device Identifier (DI) Information

Brand Name: Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
Version or Model: A9241
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078004490
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: Adult Heated Humidified Circuit, expandable up to 96"

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?
60966	Respiratory gas heating wire, adult	A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904538	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 89940c60-7ea8-4f53-aeca-ddbb0a4f66f7
Public Version Date: May 17, 2024
Public Version Number: 5
DI Record Publish Date: May 16, 2018