AccessGUDID - DEVICE: Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit (00709078005466)

GUDID

Device Identifier (DI) Information

Brand Name: Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
Version or Model: A9242
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078005466
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: No description.

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?
60928	Laparoscopy carbon dioxide gas/refillable cylinder	Compressed medical carbon dioxide (CO2) in a dedicated refillable container intended to be used for laparoscopic insufflation. The cylinder is filled with CO2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and is graded according to size (capacity) and colour-coded to denote CO2 content. It is typically made of steel and must be used together with a pressure regulator in order to release the CO2 at the correct working pressure.	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: 768ffe7d-be05-416e-be4f-71533bf76ac2
Public Version Date: March 10, 2021
Public Version Number: 3
DI Record Publish Date: June 25, 2018