AccessGUDID - DEVICE: Fisher & Paykel Healthcare (09420012422859)

GUDID

Device Identifier (DI) Information

Brand Name: Fisher & Paykel Healthcare
Version or Model: 900PT401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900PT401
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED

Primary DI Number: 09420012422859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 590153276 *Terms of Use

Device Description: Waterbag (2 Pack)

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":	No
For Single-Use:	No
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?
60662	Inspiratory line humidification chamber, reusable	A device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. This is a reusable 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 [?]
K131895	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
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80144f64-90bd-4d46-a805-20a1148cdc1c
Public Version Date: March 05, 2025
Public Version Number: 5
DI Record Publish Date: September 08, 2016